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BREASTFEEDING MEDICINE
Volume 2, Number 4, 2007
© Mary Ann Liebert, Inc.
DOI: 10.1089/bfm.2007.9984




                                       ABM Protocols

          ABM Clinical Protocol #17: Guidelines for
       Breastfeeding Infants with Cleft Lip, Cleft Palate,
                    or Cleft Lip and Palate

      SHEENA REILLY, J. REID, J. SKEAT, and THE ACADEMY OF BREASTFEEDING
                  MEDICINE CLINICAL PROTOCOL COMMITTEE


     A central goal of the Academy of Breastfeeding Medicine is the development of clinical proto-
     cols for managing common medical problems that may impact breastfeeding success. These pro-
     tocols serve only as guidelines for the care of breastfeeding mothers and infants and do not de-
     lineate an exclusive course of treatment or serve as standards of medical care. Variations in
     treatment may be appropriate according to the needs of an individual patient.



                BACKGROUND                             1000)5,6 and Caucasian populations (approxi-
                                                       mately one per 1000 births),4 and higher inci-
Definitions and incidence of cleft lip and/or palate   dence among Native American (approximately
                                                       3.5 per 1000),7,8 and Asian populations (ap-
W      HEN A CLEFT LIP (CL) occurs, the lip is not
       contiguous, and when a cleft palate (CP)
occurs, there is communication between the
                                                       proximately 1.7 per 1000).9
                                                          Although reports vary considerably, it is es-
oral and nasal cavities.1 Clefts can range in          timated that out of the total number of infants
severity from a simple notch in the upper lip          with a CL/P, approximately 50% have a com-
to a complete opening in the lip extending into        bined cleft lip and palate (CLP), while 30%
the floor of the nasal cavity and involving the        have an isolated CP, and 20% an isolated CL;
alveolus to the incisive foramen.2 Unilateral          a CL extending to include the alveolus occurs
clefts of the lip are twice as likely to be on the     in approximately 5% of cases.10 Clefts are usu-
left-hand side as the right.3 Similarly, a CP may      ally unilateral; however, in approximately 10%
involve just the soft palate or extend partially       of cases, clefts are bilateral.11
or completely through the hard and soft
palates.1 In a CP, the alveolus remains intact.
                                                       Breastfeeding and CL/P
A CP may be submucous and not immediately
detected if there are subtle or no correspond-           In these guidelines, breastfeeding refers to di-
ing clinical signs or symptoms.1                       rect placement of baby to the breast for feed-
   The worldwide prevalence of a cleft lip             ing and breastmilk feeding refers to delivery of
and/or palate (CL/P) ranges from 0.8 to 2.7            breastmilk to baby via bottle, cup, spoon, or
cases per 1000 live births.4 There are differences     any other means except breast. Babies use both
in incidence rates across racial groups, with the      suction and compression to breastfeed suc-
lowest reported incidence among African–               cessfully. The ability to generate suction is
American populations (approximately 0.5 per            necessary for attachment to the breast, mainte-

                                                   243
244                                                                                 ABM PROTOCOLS

nance of a stable feeding position and, together           the protective benefits of breastmilk. Evi-
with the let down reflex, milk extraction. Nor-            dence suggests that breastfeeding protects
mally when feeding, a baby’s lips flange firmly            against otitis media in this population.25,26
against the areola, sealing the oral cavity ante-          Additionally, there is speculative informa-
riorly. The soft palate rises up and back to con-          tion regarding possible benefits of breast-
tact the pharyngeal walls and seal the oral cav-           feeding versus bottle feeding on the devel-
ity posteriorly. As the tongue and jaw drop                opment of the oral cavity. Education of
during sucking the oral cavity increases in size           both parents before and after delivery on
and suction is generated drawing milk from the             risks of formula versus breastmilk and po-
breast.12 Compression occurs when the baby                 tential feeding difficulties and their man-
presses the breast between the tongue and jaw.             agement may be particularly important.
Suction and compression help milk transfer de-             These families may benefit from peer sup-
livery during breastfeeding.13–15                          port from other breastfeeding families with
   There is a relationship between the size of             infants with a CL/P, found through family
oral pressures generated during feeding and the            associations such as Wide Smiles, in addi-
size/type of cleft16 and maturity of the baby.             tion to routine referral for breastfeeding
For example, babies with a CL are more likely              support groups.
to breastfeed than those with a CP or CLP.17          2.   Babies with a CL/P should be evaluated for
Some babies with small clefts of the soft palate           breastfeeding on an individual basis. In
generate suction18 but others with larger clefts           particular, it is important to take into ac-
of the soft and/or hard palate may not gener-              count the size and location of the baby’s CL
ate suction.18–20 Newborns and premature ba-               and/or CP, as well as the mother’s wishes,
bies generate lower suction pressures compared             previous experience with breastfeeding,
to older babies.16,21,22 Babies with a CP or CLP           and supports. There is moderate evidence
have difficulty creating suction20,23 because the          to suggest that infants with CL are able to
oral cavity cannot be adequately separated                 generate suction,23 and descriptive reports
from the nasal cavity during feeding. A cleft              suggest that these infants are often able to
which interferes with suction (or compression)             breastfeed successfully.27 There is moder-
has the potential to impact on breastfeeding.              ate evidence that infants with a CP or CLP
   The literature describing breastfeeding out-            have difficulty generating suction18,20 and
comes in a CL/P is limited,24 anecdotal, and of-           have inefficient sucking patterns19 com-
ten contradictory. Furthermore, the popula-                pared to normal infants. The success rates
tions studied have not been well described in              for breastfeeding infants with a CP or CLP
terms of the size, location, and type (unilateral,         are observed to be lower than for infants
bilateral) of the cleft, thus affecting interpreta-        with a CL or no cleft.17,27,28
tion and usefulness of data.                          3.   As in normal breastfeeding, knowledgeable
                                                           support is important. Mothers who wish to
Aim                                                        breastfeed should be given immediate ac-
                                                           cess to a lactation advisor to assist with po-
  To develop evidence-based guidelines for
                                                           sitioning, management of milk supply, and
breastfeeding babies with clefts.
                                                           expressing milk for supplemental feeds.
                                                      4.   Mothers should be counselled about likely
                                                           breastfeeding success. Where direct breast-
           RECOMMENDATIONS                                 feeding is unlikely to be the sole feeding
                                                           method, the need for breastmilk feeding
Summary of recommendations for clinical practice
                                                           and, when appropriate, possible delayed
  Based on the reviewed evidence, the follow-              transitioning to breastfeeding should be
ing recommendations are made:                              discussed.
                                                      5.   Breastmilk feeding (via cup, spoon, bottle,
 1. As these infants are prone to otitis media,            etc.) should be promoted in preference to
    mothers should be encouraged to provide                formula feeding. In these circumstances,
ABM PROTOCOLS                                                                                          245

   assistance with hand expression/pumping                    iiv. Some experts suggest supporting the
   breastmilk should commence on day 1.                            infant’s chin to stabilize the jaw dur-
6. Monitoring of a baby’s hydration and                            ing sucking32 and/or supporting the
   weight gain may be important while a feed-                      breast so that it remains in the in-
   ing method is being established. If inade-                      fant’s mouth;33,37,42
   quate, supplemental feeding should be im-                  iiv. If the cleft is large, some experts sug-
   plemented or increased. (See ABM Protocol                       gest that the breast be tipped down-
   #3: Hospital Guidelines for the Use of Sup-                     ward to stop the nipple being
   plementary Feedings.)                                           pushed into the cleft;29
7. Modification to breastfeeding positions                    ivi. Mothers may need to manually ex-
   may increase the efficiency and effective-                      press breastmilk into the baby’s
   ness of breastfeeding. Positioning recom-                       mouth to compensate for absent suc-
   mendations that have been recommended                           tion and compression and to stimu-
   on the basis of weak evidence (clinical ex-                     late the letdown reflex.42–44
   perience or expert opinion), and should be           8. If a prosthesis is used for orthopedic align-
   evaluated for success are:                              ment prior to surgery, caution should be
    a. For infants with CL:                                used in advising parents to use such de-
       iii. The infant should be held so that the          vices to facilitate breastfeeding, as there is
            cleft lip is orientated toward the top         strong evidence that they do not signifi-
            of the breast29,30 [e.g., an infant with       cantly increase feeding efficiency or effec-
            a (R) CL may feed more efficiently in          tiveness.45,46
            a “Madonna” position at the right           9. Evidence suggests that breastfeeding can
            breast and a “football/twin style” po-         commence/recommence immediately fol-
            sition at the left breast];                    lowing CL repair,47,48 and 1 day after CP re-
       iii. The mother may occlude the CL with             pair without complication to the wound.47
            her thumb or finger7,31,32 and/or sup-     10. Assessment of the potential for breastfeed-
            port the infant’s cheeks to decrease           ing of infants with a CL/P as part of a syn-
            the width of the cleft and increase clo-       drome/sequence should be made on a
            sure around the nipple;33                      case-by-case basis, taking into account the
       iii. For bilateral CL, a “face-on” straddle         additional features of the syndrome that
            position may be more effective than            may impact on breastfeeding success.
            other breastfeeding positions.30
    b. For infants with a CP or CLP:                   Recommendations for future research
       iii. Positioning should be semi-upright            The most pressing issue for healthcare profes-
            to reduce nasal regurgitation, and re-     sionals working with mothers who wish to
            flux of breastmilk into the Eustachian     breastfeed their infants with a CL/P is the lack
            tubes;30,32,34–40                          of evidence on which to base clinical decisions.
       iii. A “football hold”/twin position            Well-designed, data-driven investigations which
            (body of infant directed away from         document feeding success rates, management
            the mother, rather than across the         strategies, and outcomes for infants with CL/P
            mother’s lap, and with the infants         are imperative. Furthermore, investigators must
            shoulders higher than its body) may        clearly describe their sample of infants and in-
            be more effective than a traditional       tervention techniques so that the research out-
            Madonna position;29                        comes are able to be generalized.
       iii. For infants with a CP it may also be
            useful to position the breast toward
            the “greater segment”—the side of                      ACKNOWLEDGMENT
            the palate which has the most intact
            bone.29 This may facilitate better           Supported in part by a grant from the Ma-
            compression and stop the nipple be-        ternal and Child Health Bureau, Department of
            ing pushed into the cleft site;41          Health and Human Services.
246                                                                                                  ABM PROTOCOLS

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38. Dixon-Wood VL. Counselling and early management                57. King NM, Samman N, So LLY, Cheung LK, Whitehill
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    Bzock KR, ed. Austin, TX: Pro-Ed, 1996, pp. 465–474.           58. Trenouth MJ, Campbell AN. Questionnaire evalua-
39. La Leche League International. Breast-feeding the                  tion of feeding methods for cleft lip and palate
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40. Balluff MA, Udin RD. Using a feeding appliance to                  Moore D, Bell H. The effects of lactation education
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    2000:6–7.                                                      63. Nagda S, Deshpande DS, Mhatre SW. Infant palatal
45. Masarei AG. An investigation of the effects of pre-                obturator. J Indian Soc Pedod Prev Dent 1996;14:24–25.
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    lip and/or palate. PhD, University College, 2003.                  obturator for infants with severe cleft lip and palate.
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    Andersen B. Infant orthopedics in UCLP: Effect on              65. Hemingway L. Breastfeeding a cleft-palate baby. Med
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    accessed August 3, 2007).                                          with a cleft palate or cleft lip and palate? CLAPA web-
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248                                                                                        ABM PROTOCOLS

72. Cohen MM, Bankier A. Syndrome delineation in-                                              Contributors
    volving oralfacial clefting. Cleft Palate Craniofac J                               *Sheena Reilly, Ph.D.
    1991;28:119–120.
                                                                               Speech Pathology Department
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    111–112.                                                            Royal Children’s Hospital, Melbourne
74. Wide Smiles. Feeding and Pierre Robin. Wide                     and Murdoch Children’s Research Institute
    Smiles website, 1997. Available at: http:/      /www.                     Melbourne, Victoria, Australia
    widesmiles.org/cleftlinks/ (last accessed August 3,
    2007).                                                                                     *J. Reid, Ph.D.
75. Pierre Robin Network. Feeding. Pierre Robin Net-                            Speech Pathology Department
    work website, 2007. Available at: http:/  /www.pierre                Royal Children’s Hospital, Melbourne
    robin.org/Feeding.htm (last accessed August 3,
                                                                                     and La Trobe University
    2007).
76. Shprintzen RJ. The implications of the diagnosis of                        Melbourne, Victoria, Australia
    Robin sequence. Cleft Palate Craniofac J 1992;29:205–
    209.
                                                                                             *J. Skeat, Ph.D.
77. Pandya AN, Boorman JG. Failure to thrive in babies                  Murdoch Children’s Research Institute
    with cleft lip and palate. Br J Plast Surg 2001;54:471–                   Melbourne, Victoria, Australia
    475.
78. Gerdes M, Solot C, Wang PP, Moss E, La Rossa D,                                       Protocol Committee
    Randall P. Cognitive and behavior profile of              Caroline J. Chantry, M.D., FABM, Co-Chairperson
    preschool children with chromosome 22q 11.2 dele-                  Cynthia R. Howard, M.D., MPH, FABM,
    tion. Am J Med Genet 1999;85:127–133.                                                        Co-Chairperson
                                                                               Ruth A. Lawrence, M.D., FABM
                                                                           Kathleen A. Marinelli, M.D., FABM,
                                                                                                Co-Chairperson
ABM protocols expire five years from the date                                  Nancy G. Powers, M.D., FABM
of publication. Evidence-based revisions are                                                          *Lead authors.
made within five years or sooner if there are
significant changes in the evidence.                                   For reprint requests: abm@bfmed.org
ABM PROTOCOLS                                                                                            249

                         APPENDIX I: FREQUENTY ASKED QUESTIONS

Breastfeeding infants with cleft lip, cleft palate, or cleft lip and palate
   Except where noted, the literature reviewed relates to infants with nonsyndromic clefts of the
lip and/or palate.

1. Can infants with a cleft lip (CL) breastfeed successfully?
There is no strong evidence with regard to breastfeeding of infants with a CL. There was moderate
(Level II-2) evidence that babies with a CL create suction during feeding.18,23 Descriptive (Level
III) studies have demonstrated successful breastfeeding at rates approaching the normal popu-
lation.27 Expert opinion (Level III) suggests that infants with CL may find breastfeeding rela-
tively more easy than bottle feeding because the breast tissue molds to the cleft and occludes
the defect more successfully than an artificial nipple.34,49–52 Expert opinion suggests that modi-
fications to positioning can facilitate breastfeeding for these infants.7,29–33

2. Can infants with a cleft palate (CP) breastfeed successfully?
There is no strong evidence with regard to breastfeeding infants with a CP. There was moderate evi-
dence (Level II-2) that infants with a CP do not create suction when bottle feeding,18,20,23 al-
though infants with clefts of the soft palate may be able to create suction.16,18 Descriptive stud-
ies indicate that breastfeeding success for infants with CP is much lower than for infants with a
CL.27,28 There was weak evidence (Level III, expert opinion) to suggest that partial breastfeeding
(with supplementation) can be achieved,35,36,51,53,54 and that the size and location of the cleft are
determining factors for breastfeeding success.31,40,43,55 As with infants with CL, modifications to
positioning are reported to increase breastfeeding success (Level III, expert opinion).30,32,34–40

3. Can infants with a cleft lip and palate (CLP) breastfeed successfully?
There is no strong evidence with regard to breastfeeding infants with a CLP. There was moderate (Level
II-2) evidence that infants with a CLP are unable to create suction when measured using a bot-
tle,16,18,23 and moderate to weak evidence that infants with CLP are sometimes able to breast-
feed successfully.51,56,57 Descriptive studies suggest breastfeeding success rates ranging from
0–40%.27,28,58 Modifications to positioning to increase breastfeeding success are recommended
by experts (Level III).29,30,32,34–40,42–44

4. Is there evidence to guide assessment and management of breastfeeding in infants with
CL/P?
Aside from strong evidence regarding the use of palatal obturators (considered separately), there was mod-
erate evidence (Level II-3) that lactation education is important to facilitate feeding efficiency in infants
with a CL/P.59 The remaining evidence is weak (Level III, expert opinion) and focuses on (a) ar-
eas for monitoring, and (b) recommendations for supplementation.

5. Is there evidence that palatal obturators facilitate breastfeeding success with infants with
a CLP or CP?
Breastfeeding outcomes may be affected by the use of feeding plates (which obturate some of
the cleft and attempt to “normalize” the oral cavity for feeding)46 or presurgical orthopedics
(prosthesis to reposition the cleft segments prior to surgery). These are collectively referred to
as “obturators” for this report. There was strong (Level I) evidence that obturators do not facilitate feed-
ing or weight gain in breastfed babies with a CLP,45 and that they do not improve the infant’s rate of bot-
tle feeding.46 There was moderate evidence (Level II-2) obturators do not facilitate suction during
bottle feeding.23 This is because obturators do not facilitate complete closure of the soft palate
against the walls of the throat during feeding. Contradictory evidence exists, supporting the use
of obturators to facilitate breastfeeding in infants with a CP or CLP, but it is from much weaker
sources (Level II-3, and Level III descriptive and case studies, and expert opinion).29,39,51,53,59–66
250                                                                                  ABM PROTOCOLS

6. Is there evidence for additional benefits of breastfeeding for infants with CL/P compared
to the normal population?
A number of moderate to weak (Level II-2 and below) studies exist, with the majority of evidence repre-
senting expert opinion (Level III). It is well accepted that breastfeeding and breastmilk feeding con-
veys positive benefits to both mother and baby. With regard to babies with a CP there was mod-
erate to weak evidence that feeding with breastmilk protects against otitis media in infants with
a CP.25,26 These babies are more prone to otitis media than the general population due to the
abnormal soft palate musculature.26,56 There was moderate to weak evidence that breastmilk can
promote intellectual development and school outcomes in babies with clefts.67,68 Expert opinion
(Level III) suggests that antibacterial agents in breastmilk promote postsurgical healing21,61,69
and reduce irritation of mucosa (compared to artificial formula).70 Additionally, experts have
suggested that breastfeeding facilitates the development of oral facial musculature,29,61
speech,29,37,66 bonding,37,61 and pacifying infants postsurgery.29,51

7. Is there evidence to indicate when it is safe to commence/recommence breastfeeding fol-
lowing surgery for lip or palate?
CL repair (cheiloplasty) is generally carried out within a few months of birth9 and CP repair
(palatoplasty) takes place between 6 and 12 months of age. There are several studies which yield
strong evidence to inform this area (Level I to Level II-2). There is moderate to strong evidence
(Levels I and II-2) that it is safe to commence/recommence breastfeeding immediately follow-
ing CL repair47,48 and moderate evidence (Level II-2) for initiating breastfeeding 1 day after CP
repair.47 There is strong evidence (Level I) that breastfeeding immediately following surgery is
more effective for weight gain, with lower hospital costs, than spoon feeding.48 Contradictory
evidence exists, but it is from weaker sources (Level III, expert opinion) and is divided as to rec-
ommendations.32–34,39,69,71

8. Is there evidence to indicate whether infants with a CP as part of a syndrome/sequence are
able to breastfeed?
There are over 340 syndromes in which CL/P appears.72 It is beyond the scope of this protocol
to review and make recommendations for them all in detail. However, some key data are pre-
sented to guide breastfeeding practice. Moderate to weak evidence suggests that, as well as the cleft,
the additional oral facial anomalies associated with these syndromes (e.g., hypotonia, micrognathia, glos-
soptosis) impact on feeding success.73–78 It is important to examine the influence of all anomalies
on feeding and design treatment with this in mind.

Method
  A systematic review of relevant literature was undertaken. The evidence was sorted and
ranked based on scientific rigor using the framework of the U.S. Preventive Services Task Force*,
as follows:

I—Strong evidence, as obtained from a randomized controlled trial, or systematic review of
RCTs.
II-1—Moderate-strong evidence, for example, obtained from well-designed controlled trials
without randomization of subjects.
II-2—Moderate evidence, obtained from cohort or case–control studies.
II-3—Moderate-weak evidence, for example, from multiple time series designs.
III—Weak evidence, based on opinions, clinical experience, descriptive studies, case reports, etc.

*U.S. Preventive Services Task Force Ratings: Strength of Recommendations and Quality of Ev-
idence. Guide to Clinical Preventive Services, Third Edition: Periodic Updates, 2000–2003.
Agency for Healthcare Research and Quality, Rockville, MD. http:/   /www.ahrq.gov/clinic/
3rduspstf/ratings.htm.

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Guidelines For Breastfeeding Infants With Cleft Lip, Cleft Palate, Or Cleft Lip And Palate

  • 1. BREASTFEEDING MEDICINE Volume 2, Number 4, 2007 © Mary Ann Liebert, Inc. DOI: 10.1089/bfm.2007.9984 ABM Protocols ABM Clinical Protocol #17: Guidelines for Breastfeeding Infants with Cleft Lip, Cleft Palate, or Cleft Lip and Palate SHEENA REILLY, J. REID, J. SKEAT, and THE ACADEMY OF BREASTFEEDING MEDICINE CLINICAL PROTOCOL COMMITTEE A central goal of the Academy of Breastfeeding Medicine is the development of clinical proto- cols for managing common medical problems that may impact breastfeeding success. These pro- tocols serve only as guidelines for the care of breastfeeding mothers and infants and do not de- lineate an exclusive course of treatment or serve as standards of medical care. Variations in treatment may be appropriate according to the needs of an individual patient. BACKGROUND 1000)5,6 and Caucasian populations (approxi- mately one per 1000 births),4 and higher inci- Definitions and incidence of cleft lip and/or palate dence among Native American (approximately 3.5 per 1000),7,8 and Asian populations (ap- W HEN A CLEFT LIP (CL) occurs, the lip is not contiguous, and when a cleft palate (CP) occurs, there is communication between the proximately 1.7 per 1000).9 Although reports vary considerably, it is es- oral and nasal cavities.1 Clefts can range in timated that out of the total number of infants severity from a simple notch in the upper lip with a CL/P, approximately 50% have a com- to a complete opening in the lip extending into bined cleft lip and palate (CLP), while 30% the floor of the nasal cavity and involving the have an isolated CP, and 20% an isolated CL; alveolus to the incisive foramen.2 Unilateral a CL extending to include the alveolus occurs clefts of the lip are twice as likely to be on the in approximately 5% of cases.10 Clefts are usu- left-hand side as the right.3 Similarly, a CP may ally unilateral; however, in approximately 10% involve just the soft palate or extend partially of cases, clefts are bilateral.11 or completely through the hard and soft palates.1 In a CP, the alveolus remains intact. Breastfeeding and CL/P A CP may be submucous and not immediately detected if there are subtle or no correspond- In these guidelines, breastfeeding refers to di- ing clinical signs or symptoms.1 rect placement of baby to the breast for feed- The worldwide prevalence of a cleft lip ing and breastmilk feeding refers to delivery of and/or palate (CL/P) ranges from 0.8 to 2.7 breastmilk to baby via bottle, cup, spoon, or cases per 1000 live births.4 There are differences any other means except breast. Babies use both in incidence rates across racial groups, with the suction and compression to breastfeed suc- lowest reported incidence among African– cessfully. The ability to generate suction is American populations (approximately 0.5 per necessary for attachment to the breast, mainte- 243
  • 2. 244 ABM PROTOCOLS nance of a stable feeding position and, together the protective benefits of breastmilk. Evi- with the let down reflex, milk extraction. Nor- dence suggests that breastfeeding protects mally when feeding, a baby’s lips flange firmly against otitis media in this population.25,26 against the areola, sealing the oral cavity ante- Additionally, there is speculative informa- riorly. The soft palate rises up and back to con- tion regarding possible benefits of breast- tact the pharyngeal walls and seal the oral cav- feeding versus bottle feeding on the devel- ity posteriorly. As the tongue and jaw drop opment of the oral cavity. Education of during sucking the oral cavity increases in size both parents before and after delivery on and suction is generated drawing milk from the risks of formula versus breastmilk and po- breast.12 Compression occurs when the baby tential feeding difficulties and their man- presses the breast between the tongue and jaw. agement may be particularly important. Suction and compression help milk transfer de- These families may benefit from peer sup- livery during breastfeeding.13–15 port from other breastfeeding families with There is a relationship between the size of infants with a CL/P, found through family oral pressures generated during feeding and the associations such as Wide Smiles, in addi- size/type of cleft16 and maturity of the baby. tion to routine referral for breastfeeding For example, babies with a CL are more likely support groups. to breastfeed than those with a CP or CLP.17 2. Babies with a CL/P should be evaluated for Some babies with small clefts of the soft palate breastfeeding on an individual basis. In generate suction18 but others with larger clefts particular, it is important to take into ac- of the soft and/or hard palate may not gener- count the size and location of the baby’s CL ate suction.18–20 Newborns and premature ba- and/or CP, as well as the mother’s wishes, bies generate lower suction pressures compared previous experience with breastfeeding, to older babies.16,21,22 Babies with a CP or CLP and supports. There is moderate evidence have difficulty creating suction20,23 because the to suggest that infants with CL are able to oral cavity cannot be adequately separated generate suction,23 and descriptive reports from the nasal cavity during feeding. A cleft suggest that these infants are often able to which interferes with suction (or compression) breastfeed successfully.27 There is moder- has the potential to impact on breastfeeding. ate evidence that infants with a CP or CLP The literature describing breastfeeding out- have difficulty generating suction18,20 and comes in a CL/P is limited,24 anecdotal, and of- have inefficient sucking patterns19 com- ten contradictory. Furthermore, the popula- pared to normal infants. The success rates tions studied have not been well described in for breastfeeding infants with a CP or CLP terms of the size, location, and type (unilateral, are observed to be lower than for infants bilateral) of the cleft, thus affecting interpreta- with a CL or no cleft.17,27,28 tion and usefulness of data. 3. As in normal breastfeeding, knowledgeable support is important. Mothers who wish to Aim breastfeed should be given immediate ac- cess to a lactation advisor to assist with po- To develop evidence-based guidelines for sitioning, management of milk supply, and breastfeeding babies with clefts. expressing milk for supplemental feeds. 4. Mothers should be counselled about likely breastfeeding success. Where direct breast- RECOMMENDATIONS feeding is unlikely to be the sole feeding method, the need for breastmilk feeding Summary of recommendations for clinical practice and, when appropriate, possible delayed Based on the reviewed evidence, the follow- transitioning to breastfeeding should be ing recommendations are made: discussed. 5. Breastmilk feeding (via cup, spoon, bottle, 1. As these infants are prone to otitis media, etc.) should be promoted in preference to mothers should be encouraged to provide formula feeding. In these circumstances,
  • 3. ABM PROTOCOLS 245 assistance with hand expression/pumping iiv. Some experts suggest supporting the breastmilk should commence on day 1. infant’s chin to stabilize the jaw dur- 6. Monitoring of a baby’s hydration and ing sucking32 and/or supporting the weight gain may be important while a feed- breast so that it remains in the in- ing method is being established. If inade- fant’s mouth;33,37,42 quate, supplemental feeding should be im- iiv. If the cleft is large, some experts sug- plemented or increased. (See ABM Protocol gest that the breast be tipped down- #3: Hospital Guidelines for the Use of Sup- ward to stop the nipple being plementary Feedings.) pushed into the cleft;29 7. Modification to breastfeeding positions ivi. Mothers may need to manually ex- may increase the efficiency and effective- press breastmilk into the baby’s ness of breastfeeding. Positioning recom- mouth to compensate for absent suc- mendations that have been recommended tion and compression and to stimu- on the basis of weak evidence (clinical ex- late the letdown reflex.42–44 perience or expert opinion), and should be 8. If a prosthesis is used for orthopedic align- evaluated for success are: ment prior to surgery, caution should be a. For infants with CL: used in advising parents to use such de- iii. The infant should be held so that the vices to facilitate breastfeeding, as there is cleft lip is orientated toward the top strong evidence that they do not signifi- of the breast29,30 [e.g., an infant with cantly increase feeding efficiency or effec- a (R) CL may feed more efficiently in tiveness.45,46 a “Madonna” position at the right 9. Evidence suggests that breastfeeding can breast and a “football/twin style” po- commence/recommence immediately fol- sition at the left breast]; lowing CL repair,47,48 and 1 day after CP re- iii. The mother may occlude the CL with pair without complication to the wound.47 her thumb or finger7,31,32 and/or sup- 10. Assessment of the potential for breastfeed- port the infant’s cheeks to decrease ing of infants with a CL/P as part of a syn- the width of the cleft and increase clo- drome/sequence should be made on a sure around the nipple;33 case-by-case basis, taking into account the iii. For bilateral CL, a “face-on” straddle additional features of the syndrome that position may be more effective than may impact on breastfeeding success. other breastfeeding positions.30 b. For infants with a CP or CLP: Recommendations for future research iii. Positioning should be semi-upright The most pressing issue for healthcare profes- to reduce nasal regurgitation, and re- sionals working with mothers who wish to flux of breastmilk into the Eustachian breastfeed their infants with a CL/P is the lack tubes;30,32,34–40 of evidence on which to base clinical decisions. iii. A “football hold”/twin position Well-designed, data-driven investigations which (body of infant directed away from document feeding success rates, management the mother, rather than across the strategies, and outcomes for infants with CL/P mother’s lap, and with the infants are imperative. Furthermore, investigators must shoulders higher than its body) may clearly describe their sample of infants and in- be more effective than a traditional tervention techniques so that the research out- Madonna position;29 comes are able to be generalized. iii. For infants with a CP it may also be useful to position the breast toward the “greater segment”—the side of ACKNOWLEDGMENT the palate which has the most intact bone.29 This may facilitate better Supported in part by a grant from the Ma- compression and stop the nipple be- ternal and Child Health Bureau, Department of ing pushed into the cleft site;41 Health and Human Services.
  • 4. 246 ABM PROTOCOLS REFERENCES 17. Reid JA, Reilly S, Kilpatrick NM. Breastmilk con- sumption in babies with clefts. 63rd Annual Meeting 1. Shprintzen RJ, Bardach J. Cleft Palate Speech Man- of the American Cleft Palate-Craniofacial Association. agement: A Multidisciplinary Approach. St Louis, Vancouver, Canada, 2006. MO: Mosby, 1995. 18. Reid J, Reilly S, Kilpatrick N. Sucking performance of 2. Shah CP, Wong D. Management of children with babies with cleft conditions. Cleft Palate Craniofac J cleft lip and palate. Can Med Assoc J 1980;122:19– 2007;44:312–320. 24. 19. Maserai AG, Sell D, Habel A, Mars M, Sommerland 3. McWilliams BJ, Morris HL, Shelton RL. Cleft Palate BC, Wade A. The nature of feeding in infants with un- Speech. Philadelphia, PA: BC Decker, 1984. repaired cleft lip and/or palate compared with 4. Vanderas AP. Incidence of cleft lip, cleft palate, and healthy noncleft infants. Cleft Palate Craniofac J 2007; cleft lip and palate among races: a review. Cleft Palate 44:321–328. J 1987;24:216–225. 20. Mizuno K, Ueda A, Kani K, Kawamura H. Feeding 5. Conway H, Wagner KJ. Incidence of clefts in New behaviour of infants with cleft lip and palate. Acta York City. Cleft Palate Craniofac J 1996;33:284–290. Paediatr 2002;91:1227–1232. 6. Croen LA, Shaw GM, Wasserman CR, Tolarov MM. 21. Jain L, Sivieri E, Abbasi S, Bhutani VK. Energetics and Racial and ethnic variations in the prevalence of oro- mechanics of nutritive sucking in the preterm and facial clefts in California, 1983–1992. Am J Med Genet term neonate. J Pediatr 1987;111(6 Pt 1):894–898. 1998;79:42–47. 22. Mizuno K, Ueda A. Development of sucking behav- 7. McClurg-Hitt D. The Breastfeeding Handbook: A ior in infants who have not been fed for 2 months af- Self-Teaching Study Guide for the Dietician. State of ter birth. Pediatr Int 2001;43:251–255. Missouri Department of Health and Senior Services 23. Choi BH, Kleinheinz J, Joos U, Komposch G. Sucking website, nd. Available at: http:/ /www.dhss.state.mo. efficiency of early orthopaedic plate and teats in in- us/dnhs_pdfs/R_NPE_pdimodule_bf.pdf (last ac- fants with cleft lip and palate. Int J Oral Maxillofac Surg cessed November 24, 2005. 1991;20:167–169. 8. Niswander JD, Barrow MV, Bingle GJ. Congenital 24. Reid J. A review of feeding interventions for infants malformations in the American Indian. Soc Biol with cleft palate. Cleft Palate Craniofac J 2004;41:268– 1975;22:203–215. 278. 9. Cleft Lip and Palate Association of Ireland. The inci- 25. Paradise JL, Elster BA, Tan L. Evidence in infants with dence of clefts. Cleft Lip and Palate Association of Ire- cleft palate that breastmilk protects against otitis me- land website, 2003. Available at: http://www.cleft.ie/ dia. Pediatrics 1994;94(6 Pt 1):853–860. what-is-a-cleft/incidence-of-clefts (last accessed Au- 26. Aniansson G, Svensson H, Becker M, Ingvarsson L. gust 3, 2007). Otitis media and feeding with breastmilk of children 10. Young G. Cleft lip and palate (UTMB Dept. of with cleft palate. Scand J Plast Reconstr Surg Hand Surg Otolaryngology Grand Rounds). University of 2002;36:9–15. Texas Medical Branch website, 1998. Available at: 27. Garcez LW, Giuliani ER. Population-based study on http://www.utmb.edu/otoref/Grnds/Cleft-lip- the practice of breastfeeding in children born with palate-9801/Cleft-lip-palate-9801.htm (last accessed cleft lip and palate. Cleft Palate Craniofac J 2005;42:687– February 10, 2006). 693. 11. Mulliken JB. Repair of bilateral complete cleft lip and 28. da Silva Dalben G, Costa B, Gomide MR, Teixeira das nasal deformity—state of the art. Cleft Palate Cranio- Neves LT. Breast-feeding and sugar intake in babies fac J 2000;37:342–347. with cleft lip and palate. Cleft Palate Craniofac J 2003; 12. Wolf LS, Glass RP. Feeding and Swallowing Disor- 40:84–87. ders in Infancy: Assessment and Management Tuc- 29. Danner SC. Breastfeeding the infant with a cleft de- son, AZ: Therapy Skill Builders, 1992. fect. NAACOGS Clin Issu Perinat Womens Health Nurs 13. Brake S, Fifer WP, Alfasi G, Fleishmann A. The first 1992;3:634–639. nutritive sucking responses of premature newborns. 30. Biancuzzo M. Clinical focus on clefts. Yes! Infants Infant Behav Dev. 1988;11:1–9. with clefts can breastfeed. AWHONN Lifelines 1998;2: 14. Anderson GC, Vidyasagar D. Development of suck- 45–49. ing in premature infants from 1 to 7 days post birth. 31. Helsing E, King FS. Breastfeeding under special con- Birth Defects Orig Artic Ser 1979;15:145–171. ditions. Nurs J of India 1985;76:46–47. 15. Weber F, Wooldridge MW, Baum JD. An ultrasono- 32. Bardach J, Morris HL. Multidisciplinary management graphic study of the organization of sucking and of cleft lip and palate Philadelphia, PA: WB Saunders swallowing by newborn infants. Dev Med Child Neu- Company, 1990. rol 1986;28:19–24. 33. Arvedson JC. Feeding with craniofacial anomalies. In: 16. Reid JA. Feeding difficulties in babies with cleft lip Pediatric swallowing and feeding: Assessment and and/or palate: An overrated problem or a ne- Management. 2nd ed. Arvedson JC, Brodsky LB, eds. glected aspect of care? PhD, La Trobe University, Albany, NY: Singular Publishing Group, 2002, pp. 2004. 527–561.
  • 5. ABM PROTOCOLS 247 34. Biavati MJ, Bassichis B. Cleft palate. E-Medicine web- 53. Curtin G. The infant with cleft lip or palate: More than site, 2003. Available at: http:/ /www.emedicine.com/ a surgical problem. J Perinat Neonat Nurs 1990;3:80–89. ent/topic136.htm (last accessed August 3rd, 2007). 54. Carlisle D. Feeding babies with cleft lip and palate. 35. Wide Smiles. Special considerations of the bottle-fed Nurs Times 1998;94:59–60. baby with a cleft. Wide Smiles website, 1996. Available 55. Grady E. Breastfeeding the baby with a cleft of the at: www.widesmiles.org (last accessed July 19, 2007). soft palate: Success and its benefits. Clin Pediatr (Phila) 36. Glass RP, Wolf LS. Feeding management of infants 1977;16:978–981. with cleft lip and palate and micrognathia. Infants 56. Gopinath VK, Muda WA. Assessment of growth and Young Child 1999;12:70–81. feeding practices in children with cleft lip and palate. 37. Dunning Y. Child nutrition. Feeding babies with cleft Southeast Asian J Trop Med Public Health 2005;36: lip and palate. Nurs Times 1986;82:46–47. 254–258. 38. Dixon-Wood VL. Counselling and early management 57. King NM, Samman N, So LLY, Cheung LK, Whitehill of feeding and language skill development for infants TL, Tideman H. The management of children born and toddlers with cleft palate. In: Communicative with cleft lip and palate. Hong Kong Med J 1996;2:153– Disorders Relating to Cleft Lip and Palate. 4th ed. 159. Bzock KR, ed. Austin, TX: Pro-Ed, 1996, pp. 465–474. 58. Trenouth MJ, Campbell AN. Questionnaire evalua- 39. La Leche League International. Breast-feeding the tion of feeding methods for cleft lip and palate baby with special healthcare needs: Cleft lip or palate neonates. Int J Paediatr Dent 1996;6:241–244. and cystic fibrosis. Exceptional Parent 1999;29:52–53. 59. Turner L, Jacobsen C, Humenczuk M, Singhal VK, 40. Balluff MA, Udin RD. Using a feeding appliance to Moore D, Bell H. The effects of lactation education aid the infant with a cleft palate. Ear Nose Throat J and a prosthetic obturator appliance on feeding effi- 1986;65:50–55. ciency in infants with cleft lip and palate. Cleft Palate 41. McKinstry RE. Presurgical management of cleft lip Craniofac J 2001;38:519–524. and palate patients. In: Cleft Palate Dentistry. Mc- 60. Redford-Badwal DA, Mabry K, Frassinelli JD. Impact Kinstry RE, ed. Arlington, VA: ABI Professional Pub- of cleft lip and/or palate on nutritional health and lications, 1998, pp. 33–66. oral-motor development. Dent Clin North Am 2003; 42. Lebair-Yenchik J. Cleft palates. AWHONN Lifelines 47:305–317. 1998;2:11–12. 61. Wilton JM. Cleft palates and breastfeeding. 43. Clarren SK, Anderson B, Wolf LS. Feeding infants AWHONN Lifelines 1998;2:11. with cleft lip, cleft palate, or cleft lip and palate. Cleft 62. Goldberg WB, Ferguson FS, Miles RJ. Successful use Palate J 1987;24:244–249. of a feeding obturator for an infant with a cleft palate. 44. Willis K. The milk of human kindness. RCSLT Bull Spec Care Dentist 1988;8:86–89. 2000:6–7. 63. Nagda S, Deshpande DS, Mhatre SW. Infant palatal 45. Masarei AG. An investigation of the effects of pre- obturator. J Indian Soc Pedod Prev Dent 1996;14:24–25. surgical orthopaedics on feeding in infants with cleft 64. Jones JE, Henderson L, Avery DR. Use of a feeding lip and/or palate. PhD, University College, 2003. obturator for infants with severe cleft lip and palate. 46. Prahl C, Kuijpers-Jagtman AM, van’t Hof MA, Prahl- Spec Care Dentist 1982;2:116–120. Andersen B. Infant orthopedics in UCLP: Effect on 65. Hemingway L. Breastfeeding a cleft-palate baby. Med feeding, weight, and length: A randomized clinical J Aust 1972;2:626. trial (Dutchcleft). Cleft Palate Craniofac J 2005;42: 66. World Health Organization. Health factors which 171–177. may interfere with breast-feeding. Bull World Health 47. Cohen M, Marschall MA, Schafer ME. Immediate un- Organ 1989;67(Suppl):41–54. restricted feeding of infants following cleft lip and 67. Chen Z, Chen J, Wu J, Zhang X. Factors involved in palate repair. J Craniofac Surg 1992;3:30–32. intelligent development of children with cleft lip and 48. Darzi MA, Chowdri NA, Bhat AN. Breastfeeding or palate [Chinese]. Hua Xi Kou Qiang Yi Xue Za Zhi spoon feeding after cleft lip repair: a prospective, ran- 2001;19:174–177. domised study. Br J Plast Surg 1996;49:24–26. 68. Erkkila AT, Isotalo E, Pulkkinen J, Haapenen ML. As- 49. Young JL, O’Riordan M, Goldstein JA, Robin NH. sociation between school performance, breastmilk What information do parents of newborns with cleft intake and fatty acid profile of serum lipids in ten- lip, palate, or both want to know? Cleft Palate Cranio- year-old cleft children. J Craniofac Surg 2005;16:764– fac J 2001;38:55–58. 769. 50. Cleft Lip and Palate Association. Feeding babies with 69. McCartney J. Supplementing the breastfed infant with a cleft lip? CLAPA website, 2007. Available at: a cleft. Wide Smiles website, 1996. http:/ /www.clapa.com/faqs.php?topic_id 14 (last 70. Cleft Lip and Palate Association. How to feed babies accessed August 3, 2007). with a cleft palate or cleft lip and palate? CLAPA web- 51. Kelts D, Jones E. Selected topics in therapeutic nutri- site, 2007. Available at: http:/ /www.clapa.com/faqs. tion. Curr Prob Pediatr 1983;13:1–62. php?topic_id 15 (last accessed August 3, 2007). 52. Martin WL, Gornall P, Kilby MD. Cleft lip and palate. 71. Jacobs SC. Nursing care of the child with cleft lip Fetal Matern Med Rev 1999;11:91–104. and/or palate. Plast Surg Nurs 1983;3:61–65.
  • 6. 248 ABM PROTOCOLS 72. Cohen MM, Bankier A. Syndrome delineation in- Contributors volving oralfacial clefting. Cleft Palate Craniofac J *Sheena Reilly, Ph.D. 1991;28:119–120. Speech Pathology Department 73. Landis J. Pierre Robin sequence. LEAVEN 2001;37: 111–112. Royal Children’s Hospital, Melbourne 74. Wide Smiles. Feeding and Pierre Robin. Wide and Murdoch Children’s Research Institute Smiles website, 1997. Available at: http:/ /www. Melbourne, Victoria, Australia widesmiles.org/cleftlinks/ (last accessed August 3, 2007). *J. Reid, Ph.D. 75. Pierre Robin Network. Feeding. Pierre Robin Net- Speech Pathology Department work website, 2007. Available at: http:/ /www.pierre Royal Children’s Hospital, Melbourne robin.org/Feeding.htm (last accessed August 3, and La Trobe University 2007). 76. Shprintzen RJ. The implications of the diagnosis of Melbourne, Victoria, Australia Robin sequence. Cleft Palate Craniofac J 1992;29:205– 209. *J. Skeat, Ph.D. 77. Pandya AN, Boorman JG. Failure to thrive in babies Murdoch Children’s Research Institute with cleft lip and palate. Br J Plast Surg 2001;54:471– Melbourne, Victoria, Australia 475. 78. Gerdes M, Solot C, Wang PP, Moss E, La Rossa D, Protocol Committee Randall P. Cognitive and behavior profile of Caroline J. Chantry, M.D., FABM, Co-Chairperson preschool children with chromosome 22q 11.2 dele- Cynthia R. Howard, M.D., MPH, FABM, tion. Am J Med Genet 1999;85:127–133. Co-Chairperson Ruth A. Lawrence, M.D., FABM Kathleen A. Marinelli, M.D., FABM, Co-Chairperson ABM protocols expire five years from the date Nancy G. Powers, M.D., FABM of publication. Evidence-based revisions are *Lead authors. made within five years or sooner if there are significant changes in the evidence. For reprint requests: abm@bfmed.org
  • 7. ABM PROTOCOLS 249 APPENDIX I: FREQUENTY ASKED QUESTIONS Breastfeeding infants with cleft lip, cleft palate, or cleft lip and palate Except where noted, the literature reviewed relates to infants with nonsyndromic clefts of the lip and/or palate. 1. Can infants with a cleft lip (CL) breastfeed successfully? There is no strong evidence with regard to breastfeeding of infants with a CL. There was moderate (Level II-2) evidence that babies with a CL create suction during feeding.18,23 Descriptive (Level III) studies have demonstrated successful breastfeeding at rates approaching the normal popu- lation.27 Expert opinion (Level III) suggests that infants with CL may find breastfeeding rela- tively more easy than bottle feeding because the breast tissue molds to the cleft and occludes the defect more successfully than an artificial nipple.34,49–52 Expert opinion suggests that modi- fications to positioning can facilitate breastfeeding for these infants.7,29–33 2. Can infants with a cleft palate (CP) breastfeed successfully? There is no strong evidence with regard to breastfeeding infants with a CP. There was moderate evi- dence (Level II-2) that infants with a CP do not create suction when bottle feeding,18,20,23 al- though infants with clefts of the soft palate may be able to create suction.16,18 Descriptive stud- ies indicate that breastfeeding success for infants with CP is much lower than for infants with a CL.27,28 There was weak evidence (Level III, expert opinion) to suggest that partial breastfeeding (with supplementation) can be achieved,35,36,51,53,54 and that the size and location of the cleft are determining factors for breastfeeding success.31,40,43,55 As with infants with CL, modifications to positioning are reported to increase breastfeeding success (Level III, expert opinion).30,32,34–40 3. Can infants with a cleft lip and palate (CLP) breastfeed successfully? There is no strong evidence with regard to breastfeeding infants with a CLP. There was moderate (Level II-2) evidence that infants with a CLP are unable to create suction when measured using a bot- tle,16,18,23 and moderate to weak evidence that infants with CLP are sometimes able to breast- feed successfully.51,56,57 Descriptive studies suggest breastfeeding success rates ranging from 0–40%.27,28,58 Modifications to positioning to increase breastfeeding success are recommended by experts (Level III).29,30,32,34–40,42–44 4. Is there evidence to guide assessment and management of breastfeeding in infants with CL/P? Aside from strong evidence regarding the use of palatal obturators (considered separately), there was mod- erate evidence (Level II-3) that lactation education is important to facilitate feeding efficiency in infants with a CL/P.59 The remaining evidence is weak (Level III, expert opinion) and focuses on (a) ar- eas for monitoring, and (b) recommendations for supplementation. 5. Is there evidence that palatal obturators facilitate breastfeeding success with infants with a CLP or CP? Breastfeeding outcomes may be affected by the use of feeding plates (which obturate some of the cleft and attempt to “normalize” the oral cavity for feeding)46 or presurgical orthopedics (prosthesis to reposition the cleft segments prior to surgery). These are collectively referred to as “obturators” for this report. There was strong (Level I) evidence that obturators do not facilitate feed- ing or weight gain in breastfed babies with a CLP,45 and that they do not improve the infant’s rate of bot- tle feeding.46 There was moderate evidence (Level II-2) obturators do not facilitate suction during bottle feeding.23 This is because obturators do not facilitate complete closure of the soft palate against the walls of the throat during feeding. Contradictory evidence exists, supporting the use of obturators to facilitate breastfeeding in infants with a CP or CLP, but it is from much weaker sources (Level II-3, and Level III descriptive and case studies, and expert opinion).29,39,51,53,59–66
  • 8. 250 ABM PROTOCOLS 6. Is there evidence for additional benefits of breastfeeding for infants with CL/P compared to the normal population? A number of moderate to weak (Level II-2 and below) studies exist, with the majority of evidence repre- senting expert opinion (Level III). It is well accepted that breastfeeding and breastmilk feeding con- veys positive benefits to both mother and baby. With regard to babies with a CP there was mod- erate to weak evidence that feeding with breastmilk protects against otitis media in infants with a CP.25,26 These babies are more prone to otitis media than the general population due to the abnormal soft palate musculature.26,56 There was moderate to weak evidence that breastmilk can promote intellectual development and school outcomes in babies with clefts.67,68 Expert opinion (Level III) suggests that antibacterial agents in breastmilk promote postsurgical healing21,61,69 and reduce irritation of mucosa (compared to artificial formula).70 Additionally, experts have suggested that breastfeeding facilitates the development of oral facial musculature,29,61 speech,29,37,66 bonding,37,61 and pacifying infants postsurgery.29,51 7. Is there evidence to indicate when it is safe to commence/recommence breastfeeding fol- lowing surgery for lip or palate? CL repair (cheiloplasty) is generally carried out within a few months of birth9 and CP repair (palatoplasty) takes place between 6 and 12 months of age. There are several studies which yield strong evidence to inform this area (Level I to Level II-2). There is moderate to strong evidence (Levels I and II-2) that it is safe to commence/recommence breastfeeding immediately follow- ing CL repair47,48 and moderate evidence (Level II-2) for initiating breastfeeding 1 day after CP repair.47 There is strong evidence (Level I) that breastfeeding immediately following surgery is more effective for weight gain, with lower hospital costs, than spoon feeding.48 Contradictory evidence exists, but it is from weaker sources (Level III, expert opinion) and is divided as to rec- ommendations.32–34,39,69,71 8. Is there evidence to indicate whether infants with a CP as part of a syndrome/sequence are able to breastfeed? There are over 340 syndromes in which CL/P appears.72 It is beyond the scope of this protocol to review and make recommendations for them all in detail. However, some key data are pre- sented to guide breastfeeding practice. Moderate to weak evidence suggests that, as well as the cleft, the additional oral facial anomalies associated with these syndromes (e.g., hypotonia, micrognathia, glos- soptosis) impact on feeding success.73–78 It is important to examine the influence of all anomalies on feeding and design treatment with this in mind. Method A systematic review of relevant literature was undertaken. The evidence was sorted and ranked based on scientific rigor using the framework of the U.S. Preventive Services Task Force*, as follows: I—Strong evidence, as obtained from a randomized controlled trial, or systematic review of RCTs. II-1—Moderate-strong evidence, for example, obtained from well-designed controlled trials without randomization of subjects. II-2—Moderate evidence, obtained from cohort or case–control studies. II-3—Moderate-weak evidence, for example, from multiple time series designs. III—Weak evidence, based on opinions, clinical experience, descriptive studies, case reports, etc. *U.S. Preventive Services Task Force Ratings: Strength of Recommendations and Quality of Ev- idence. Guide to Clinical Preventive Services, Third Edition: Periodic Updates, 2000–2003. Agency for Healthcare Research and Quality, Rockville, MD. http:/ /www.ahrq.gov/clinic/ 3rduspstf/ratings.htm.