This is the current release of the guideline.

Academy of Breastfeeding Medicine protocols expire five years from the date of publication. Evidence-based revisions are made within five years or sooner if there are significant changes in evidence.

• Cleft lip and/or cleft palate
• Newborn/infant health and nutrition

Counseling
Evaluation
Management
Prevention
Risk Assessment

Family Practice
Nursing
Nutrition
Obstetrics and Gynecology
Pediatrics

Advanced Practice Nurses
Allied Health Personnel
Dietitians
Nurses
Physician Assistants
Physicians

To develop evidence-based guidelines for breastfeeding babies with clefts

Nursing mothers and their newborn infants with cleft lip, cleft palate, or cleft lip and palate

Evaluation/Management

1. Individualized assessment for breastfeeding potential
   • Size and location of cleft lip (CL), cleft palate (CP), and/or cleft lip and palate (CLP)
   • Infant's sucking pattern
2. Referral to lactation advisor as appropriate
3. Parental education and counseling
   • Benefits of breastfeeding versus formula/bottle feeding
   • Risks of formula/bottle feeding
   • Assistance with hand expression/pumping breastmilk
   • Likelihood of breastfeeding success
4. Monitoring of infant's hydration and nutritional status
5. Promotion of breastfeeding or breastmilk feeding
   • Modification to breastfeeding positions for infants with CL, CP, or CLP as necessary
6. Appropriate and cautious use of prosthesis for orthopedic alignment
7. Commencement of breastfeeding after CL and CP repair

• Incidence and prevalence of cleft lip, cleft palate, and/or cleft lip and palate
• Ability to successfully breastfeed

Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases

An initial search of relevant published articles written in English in the past 20 years in the fields of medicine, psychiatry, psychology, and basic biological science is undertaken for a particular topic. Once the articles are gathered, the papers are evaluated for scientific accuracy and significance.

Not stated

Expert Consensus (Committee)
Weighting According to a Rating Scheme (Scheme Given)

Levels of Evidence

I Evidence obtained from at least one properly randomized controlled trial

II-1 Evidence obtained from well-designed controlled trials without randomization

II-2 Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group

II-3 Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled experiments (such as the results of the introduction of penicillin treatment in the 1940s) could also be regarded as this type of evidence.

III Opinions of respected authorities, based on clinical experience, descriptive studies and case reports; or reports of expert committees

Systematic Review with Evidence Tables

An expert panel is identified and appointed to develop a draft protocol using evidence based methodology. An annotated bibliography (literature review), including salient gaps in the literature, are submitted by the expert panel to the Protocol Committee.

Expert Consensus

Not stated

Not applicable

A formal cost analysis was not performed and published cost analyses were not reviewed.

External Peer Review
Internal Peer Review

Draft protocol is peer reviewed by individuals outside of lead author/expert panel, including specific review for international applicability. Protocol Committee's sub-group of international experts recommends appropriate international reviewers. Chair (co-chairs) institutes and facilitates process.

Reviews submitted to committee Chair (co-chairs).

Draft protocol is submitted to The Academy of Breastfeeding Medicine (ABM) Board for review and approval. Comments for revision will be accepted for three weeks following submission. Chair (co-chairs) and protocol author(s) amends protocol as needed.

Following all revisions, protocol has final review by original author(s) to make final suggestions and ascertain whether to maintain lead authorship.

Final protocol is submitted to the Board of Directors of ABM for approval.

Based on the reviewed evidence, the following recommendations are made:

1. As these infants are prone to otitis media, mothers should be encouraged to provide the protective benefits of breastmilk. Evidence suggests that breastfeeding protects against otitis media in this population (Paradise, Elster & Tan, 1994; Aniansson et al., 2002). Additionally, there is speculative information regarding possible benefits of breastfeeding versus bottle feeding on the development of the oral cavity. Education of both parents before and after delivery on risks of formula versus breastmilk and potential feeding difficulties and their management may be particularly important. These families may benefit from peer support from other breastfeeding families with infants with a cleft lip/palate (CL/P), found through family associations such as Wide Smiles, in addition to routine referral for breastfeeding support groups.
2. Babies with a CL/P should be evaluated for breastfeeding on an individual basis. In particular, it is important to take into account the size and location of the baby's CL and/or CP, as well as the mother's wishes, previous experience with breastfeeding, and supports. There is moderate evidence to suggest that infants with CL are able to generate suction, (Choi et al., 1991) and descriptive reports suggest that these infants are often able to breastfeed successfully (Garcez & Giugliani, 2005). There is moderate evidence that infants with a CP or CLP have difficulty generating suction (Reid, Reilly & Kilpatrick, 2007; Mizuno et al., 2002) and have inefficient sucking patterns (Masarei et al., 2007) compared to normal infants. The success rates for breastfeeding infants with a CP or CLP are observed to be lower than for infants with a CL or no cleft (Reid, Reilly & Kilpatrick, 2006; Garcez & Giuliani, 2005; da Silva et al., 2003).
3. As in normal breastfeeding, knowledgeable support is important. Mothers who wish to breastfeed should be given immediate access to a lactation advisor to assist with positioning, management of milk supply, and expressing milk for supplemental feeds.
4. Mothers should be counselled about likely breastfeeding success. Where direct breastfeeding is unlikely to be the sole feeding method, the need for breastmilk feeding and, when appropriate, possible delayed transitioning to breastfeeding should be discussed.
5. Breastmilk feeding (via cup, spoon, bottle, etc.) should be promoted in preference to formula feeding. In these circumstances, assistance with hand expression/pumping breastmilk should commence on day 1.
6. Monitoring of a baby's hydration and weight gain may be important while a feeding method is being established. If inadequate, supplemental feeding should be implemented or increased. (See ABM Protocol #3: Hospital Guidelines for the Use of Supplementary Feedings.)
7. Modification to breastfeeding positions may increase the efficiency and effectiveness of breastfeeding. Positioning recommendations that have been recommended on the basis of weak evidence (clinical experience or expert opinion), and should be evaluated for success are:
   • For infants with CL:
     • The infant should be held so that the cleft lip is orientated toward the top of the breast (Danner, 1992; Biancuzzo, 1998), (e.g., an infant with a [R] CL may feed more efficiently in a "Madonna" position at the right breast and a "football/twin style" position at the left breast)
     • The mother may occlude the CL with her thumb or finger (McClurg-Hitt, 2005; Helsing & King, 1985; Bardach & Morris, 1990) and/or support the infant's cheeks to decrease the width of the cleft and increase closure around the nipple (Arvedson, 2002)
     • For bilateral CL, a "face-on" straddle position may be more effective than other breastfeeding positions (Biancuzzo, 1998)
   • For infants with a CP or CLP:
     • Positioning should be semi-upright to reduce nasal regurgitation, and reflux of breastmilk into the Eustachian tubes (Biancuzzo, 1998; Bardach & Morris, 1990; Biavati & Bassichis, 2003; Wide Smiles, 1996; Glass & Wolf, 1999; Dunning, 1986; Dixon-Wood, 1996; La Leche League International, 1999; Balluff & Udin, 1986)
     • A "football hold"/twin position (body of infant directed away from the mother, rather than across the mother's lap, and with the infants shoulders higher than its body) may be more effective than a traditional Madonna position (Danner, 1992)
     • For infants with a CP it may also be useful to position the breast toward the "greater segment"—the side of the palate which has the most intact bone (Danner, 1992). This may facilitate better compression and stop the nipple being pushed into the cleft site (McKinstry, 1998)
     • Some experts suggest supporting the infant's chin to stabilize the jaw during sucking (Bardach & Morris, 1990) and/or supporting the breast so that it remains in the infant's mouth (Arvedson, 2002; Dunning, 1986; Lebair-Yenchik, 1998)
     • If the cleft is large, some experts suggest that the breast be tipped downward to stop the nipple being pushed into the cleft (Danner, 1992)
     • Mothers may need to manually express breastmilk into the baby's mouth to compensate for absent suction and compression and to stimulate the letdown reflex (Lebair-Yenchik, 1998; Clarren, Anderson & Wolf, 1987; Willis, 2000)
8. If a prosthesis is used for orthopedic alignment prior to surgery, caution should be used in advising parents to use such devices to facilitate breastfeeding, as there is strong evidence that they do not significantly increase feeding efficiency or effectiveness (Maserai, 2003; Prahl, Kuijpers-Jagtman & van't Hof, 2005).
9. Evidence suggests that breastfeeding can commence/recommence immediately following CL repair, (Cohen, Marschall & Schafer, 1992; Darzi, Chowdri & Bhat 1996) and 1 day after CP repair without complication to the wound (Cohen, Marschall & Schafer, 1992).
10. Assessment of the potential for breastfeeding of infants with a CL/P as part of a syndrome/sequence should be made on a case-by-case basis, taking into account the additional features of the syndrome that may impact on breastfeeding success.

None provided

The type of evidence supporting the recommendations is not specifically stated.

The recommendations were based primarily on a comprehensive review of the existing literature. In cases where the literature does not appear conclusive, recommendations were based on the consensus opinion of the group of experts.

Appropriate management of breastfeeding in infants with cleft lip, cleft palate, or cleft lip and palate

If a prosthesis is used for orthopedic alignment prior to surgery, caution should be used in advising parents to use such devices to facilitate breastfeeding, as there is strong evidence that they do not significantly increase feeding efficiency or effectiveness.

A central goal of the Academy of Breastfeeding Medicine is the development of clinical protocols for managing common medical problems that may impact breastfeeding success. These protocols serve only as guidelines for the care of breastfeeding mothers and infants and do not delineate 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.

An implementation strategy was not provided.

Living with Illness
Staying Healthy

Effectiveness
Patient-centeredness

Not applicable: The guideline was not adapted from another source.

2007

Academy of Breastfeeding Medicine - Professional Association

Academy of Breastfeeding Medicine

A grant from the Maternal and Child Health Bureau, U.S. Department of Health and Human Services

Academy of Breastfeeding Medicine Protocol Committee

Committee Members: Caroline J. Chantry, MD, FABM, Co-Chairperson; Cynthia R. Howard, MD, MPH, FABM, Co-Chairperson; Ruth A. Lawrence, MD, FABM; Kathleen A. Marinelli, MD, FABM, Co-Chairperson; Nancy G. Powers, MD, FABM

Contributors: *Sheena Reilly, PhD, Speech Pathology Department, Royal Children's Hospital, Melbourne and Murdoch Children's Research Institute, Melbourne, Victoria, Australia; *J. Reid, PhD, Speech Pathology Department, Royal Children's Hospital, Melbourne and La Trobe University, Melbourne, Victoria, Australia; *J. Skeat, PhD, Murdoch Children's Research Institute, Melbourne, Victoria, Australia

*Lead authors

Not stated

This is the current release of the guideline.

Academy of Breastfeeding Medicine protocols expire five years from the date of publication. Evidence-based revisions are made within five years or sooner if there are significant changes in evidence.

None available

This NGC summary was completed by ECRI Institute on March 23, 2009. The information was verified by the guideline developer on September 10, 2009.