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Guideline Summary
Guideline Title
Best evidence statement (BESt). Maternal dietary antigen avoidance in lactation.
Bibliographic Source(s)
Cincinnati Children's Hospital Medical Center. Best evidence statement (BESt). Maternal dietary antigen avoidance in lactation. Cincinnati (OH): Cincinnati Children's Hospital Medical Center; 2009 Sep 25. 6 p. [26 references]
Guideline Status

This is the current release of the guideline.

Scope

Disease/Condition(s)
  • Lactation
  • Food allergy
  • Atopic disease (eczema)
  • Colic
  • Bloody stool
Guideline Category
Assessment of Therapeutic Effectiveness
Counseling
Prevention
Treatment
Clinical Specialty
Allergy and Immunology
Family Practice
Nutrition
Obstetrics and Gynecology
Pediatrics
Preventive Medicine
Intended Users
Advanced Practice Nurses
Dietitians
Nurses
Physician Assistants
Physicians
Guideline Objective(s)

To provide recommendations for prevention and treatment of atopic disease in infants

Target Population

Breastfeeding mothers and their infants

Interventions and Practices Considered

Prevention

Primary prevention of atopic disease:

  • Exclusive human milk for four months
  • Elimination diet in pregnancy and lactation (not recommended)

Treatment

Treatment of infant atopy, bloody stools, or colic:

  • Dietary counseling
  • Elimination diets for breastfeeding mothers (note: insufficient evidence and lack of consensus to make a recommendation)
  • Low allergen maternal diet
  • Allergenic food avoidance, if confirmed food allergy
Major Outcomes Considered
  • Incidence of atopic disease
  • Improvement in symptoms of colic and bloody stools
  • Eczema severity score

Methodology

Methods Used to Collect/Select the Evidence
Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

Search Strategy

  1. OVID EBM Reviews (Cochrane) 
    • Limit set for English language
    • Keywords: maternal diet and lactation
  2. PUBMED MEDLINE
    • Limits set for English language, 2004 to present
    • Medical Subject Headings (MeSH): Allergens [*administration & dosage]; Dietary Proteins [*administration & dosage]; Hypersensitivity, Immediate [*prevention & control]; Infant, Newborn; Lactation; Randomized Controlled Trials as Topic; Risk Factors
  3. CINAHL
    • Limits set for English language, Exclude MEDLINE records
    • Search terms: maternal diet and lactation
  4. Online search for practice guidelines: AHRQ, TRIP, Medscape, Netting the Evidence, Joanna Briggs, UpToDate
  5. Additional articles identified from reference lists of retrieved articles and guidelines
Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Table of Evidence Levels

Quality Level Definition
1a† or 1b† Systematic review, meta-analysis, or meta-synthesis of multiple studies
2a or 2b Best study design for domain
3a or 3b Fair study design for domain
4a or 4b Weak study design for domain
5 Other: General review, expert opinion, case report, consensus report, or guideline

†a = good quality study; b = lesser quality study

Note: Full tables of evidence grades and strength of recommendations are available in separate documents (see the "Availability of Companion Documents" field).

Methods Used to Analyze the Evidence
Review of Published Meta-Analyses
Systematic Review
Description of the Methods Used to Analyze the Evidence

Not stated

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

Not stated

Rating Scheme for the Strength of the Recommendations

Table of Recommendation Strength

Strength Definition
"Strongly recommended" There is consensus that benefits clearly outweigh risks and burdens (or vice-versa for negative recommendations).
"Recommended" There is consensus that benefits are closely balanced with risks and burdens.
No recommendation made There is a lack of consensus to direct development of a recommendation.
Dimensions: In determining the strength of a recommendation, the development group makes a considered judgment in a consensus process that incorporates critically appraised evidence, clinical experience, and other dimensions as listed below.
  1. Grade of the Body of Evidence
  2. Safety/Harm
  3. Health benefit to the patients (direct benefit)
  4. Burden to patient of adherence to recommendation (cost, hassle, discomfort, pain, motivation, ability to adhere, time)
  5. Cost-effectiveness to healthcare system (balance of cost/savings of resources, staff time, and supplies based on published studies or onsite analysis)
  6. Directness (the extent to which the body of evidence directly answers the clinical question [population/problem, intervention, comparison, outcome])
  7. Impact on morbidity/mortality or quality of life

Note: Full tables of evidence grades and strength of recommendations are available in separate documents (see the "Availability of Companion Documents" field).

Cost Analysis

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

Method of Guideline Validation
Peer Review
Description of Method of Guideline Validation

Reviewed by Clinical Effectiveness

Recommendations

Major Recommendations

The strength of the recommendation (strongly recommended, recommended, or no recommendation) and the quality of the evidence (1a to 5) are defined at the end of the "Major Recommendations" field.

Diet Recommendations Related to the Primary Prevention of Atopic Disease

  1. It is recommended that infants at high risk for developing atopic disease receive exclusive human milk feedings for at least the first four months of life (Gdalevich et at., 2001 [1a]; Schoetzau et al., 2002 [3a]; Greer, Sicherer, & Burks, 2008 [5a]; Zeiger, 2003 [5a]).
  2. It is recommended that mothers not follow an elimination diet in pregnancy or during lactation as this has not been shown to prevent the development of atopic disease in children (Kramer & Kakuma, 2006 [1a]; Palmer, Gold, & Makrides, 2005 [2a]; Vance et al., 2004 [2b]; Lovegrove, Hampton, & Morgan, 1994 [2b]; Lilja et al., 1991 [2b]; Fleischer, 2008 [5a]; Greer, Sicherer, & Burks, 2008 [5a]).

    Note: A 2006 Cochrane review (Kramer & Kakuma, 2006 [1a]) concluded that there was insufficient evidence that antigen avoidance during lactation was beneficial in preventing atopic disease in the breastfed infant, with the exception of atopic dermatitis. Due to methodologic shortcomings of the available published trials, more data are necessary to conclude that avoidance of antigens during lactation prevents atopic dermatitis in infants (Greer, Sicherer, & Burks, 2008 [5a]).

Diet Recommendations Related to the Primary Treatment of Infant Atopy, Bloody Stools, or Colic Symptoms

  1. It is recommended that breastfeeding mothers receive dietary counseling to prevent nutritional deficiencies when they eliminate essential foods from their diet (Kramer & Kakuma, 2006 [1a]; Fleischer, 2008 [5a], Lifschitz, 2008 [5a]; Noimark & Cox, 2008 [5a]; Zeiger, 2003 [5a]).
  2. There is insufficient evidence and a lack of consensus to make a recommendation on elimination diets for breastfeeding mothers of children with atopic eczema.

    Note: One crossover trial (n=17) (Cant et al., 1986 [2b]) found that dietary antigen avoidance by mothers of infants with atopic eczema was associated with a non-significant reduction in infant eczema severity scores.

  3. It is recommended that the clinician consider a low allergen diet for breastfeeding mothers to reduce symptoms of colic in infants younger than six weeks (Garrison & Christakis, 2000 [1a]; Hill et al., 2005 [2a]; Hill et al., 1995 [2b]; Heine, 2008 [5a]).

    Note: A low allergen maternal diet would begin with the elimination of milk and soy and progress to elimination of a greater variety of antigenic foods (eggs, wheat, peanuts, tree nuts, and fish) as needed to decrease infant colic symptoms under the guidance of a Registered Dietitian. Colic is self-limiting and stepwise reintroduction of the eliminated foods should be attempted as soon as possible (Heine, 2008 [5a]).

  4. It is recommended that the clinician consider a trial low allergen maternal diet to manage breastfed infant symptoms of allergic colitis (Local Consensus [5]; Lifschitz, 2008 [5a]; Lake, 2000 [5a], Perisic, Filipovic, & Kokai, 1988 [5a]; Lake, Whitington, & Hamilton, 1982 [5b]).

    Note: A low allergen maternal diet would begin with complete elimination of cow's milk protein and progress to elimination of soy protein if symptoms persist. Resolution of bloody stools within 72 to 96 hours after elimination of the offending protein would be expected (Lake, 2000 [5a]).

  5. It is recommended that for infants with a confirmed food allergy, the causal food not be consumed by the breastfeeding mother (Noimark & Cox, 2008 [5a]; Zeiger, 2003 [5a]; Lifschitz et al., 1988 [5a]).

Definitions:

Table of Evidence Levels

Quality Level Definition
1a† or 1b† Systematic review, meta-analysis, or meta-synthesis of multiple studies
2a or 2b Best study design for domain
3a or 3b Fair study design for domain
4a or 4b Weak study design for domain
5 Other: General review, expert opinion, case report, consensus report, or guideline

†a = good quality study; b = lesser quality study

Table of Recommendation Strength

Strength Definition
"Strongly recommended" There is consensus that benefits clearly outweigh risks and burdens (or vice-versa for negative recommendations).
"Recommended" There is consensus that benefits are closely balanced with risks and burdens.
No recommendation made There is a lack of consensus to direct development of a recommendation.
Dimensions: In determining the strength of a recommendation, the development group makes a considered judgment in a consensus process that incorporates critically appraised evidence, clinical experience, and other dimensions as listed below.
  1. Grade of the Body of Evidence
  2. Safety/Harm
  3. Health benefit to the patients (direct benefit)
  4. Burden to patient of adherence to recommendation (cost, hassle, discomfort, pain, motivation, ability to adhere, time)
  5. Cost-effectiveness to healthcare system (balance of cost/savings of resources, staff time, and supplies based on published studies or onsite analysis)
  6. Directness (the extent to which the body of evidence directly answers the clinical question [population/problem, intervention, comparison, outcome])
  7. Impact on morbidity/mortality or quality of life

Note: Full tables of evidence grades and strength of recommendations are available in separate documents (see the "Availability of Companion Documents" field).

Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

References Supporting the Recommendations
Type of Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for each recommendation (see the "Major Recommendations" field.)

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits
  • Prevention or delay of development of atopic disease
  • Reduction or elimination of infant atopy, bloody stools, and /or colic symptoms
Potential Harms

Maternal nutritional deficiency due to dietary restriction

Qualifying Statements

Qualifying Statements

This Best Evidence Statement addresses only key points of care for the target population; it is not intended to be a comprehensive practice guideline. These recommendations result from review of literature and practices current at the time of their formulation. This Best Evidence Statement does not preclude using care modalities proven efficacious in studies published subsequent to the current revision of this document. This document is not intended to impose standards of care preventing selective variances from the recommendations to meet the specific and unique requirements of individual patients. Adherence to this Statement is voluntary. The clinician in light of the individual circumstances presented by the patient must make the ultimate judgment regarding the priority of any specific procedure.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Getting Better
Staying Healthy
IOM Domain
Effectiveness
Patient-centeredness

Identifying Information and Availability

Bibliographic Source(s)
Cincinnati Children's Hospital Medical Center. Best evidence statement (BESt). Maternal dietary antigen avoidance in lactation. Cincinnati (OH): Cincinnati Children's Hospital Medical Center; 2009 Sep 25. 6 p. [26 references]
Adaptation

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

Date Released
2009 Sep 25
Guideline Developer(s)
Cincinnati Children's Hospital Medical Center - Hospital/Medical Center
Source(s) of Funding

Cincinnati Children's Hospital Medical Center

Guideline Committee

Not stated

Composition of Group That Authored the Guideline

Group/Team Leader: Betsy List, MPH, RN, IBCLC, Health Policy & Clinical Effectiveness

Group/Team Members: Amal Assa'ad, MD, Division of Allergy & Immunology; Michael Farrell, MD, Chief of Staff; Mandy Monty, RD, LD, Division of Nutrition Therapy; Sarah Riddle, MD, IBCLC, Division of General & Community Pediatrics; Terri Rutz, BSN, RN, IBCLC, Division of Nutrition Therapy

Support Personnel: Eloise Clark, MPH, MBA, Health Policy & Clinical Effectiveness

Financial Disclosures/Conflicts of Interest

Not stated

Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Available from the Cincinnati Children's Hospital Medical Center External Web Site Policy.

Print copies: For information regarding the full-text guideline, print copies, or evidence-based practice support services contact the Cincinnati Children's Hospital Medical Center Health James M. Anderson Center for Health Systems Excellence at EBDMInfo@cchmc.org.

Availability of Companion Documents

The following are available:

  • Judging the strength of a recommendation. Cincinnati (OH): Cincinnati Children's Hospital Medical Center; 2008 Jan. 1 p.
  • Grading a body of evidence to answer a clinical question. Cincinnati (OH): Cincinnati Children's Hospital Medical Center; 1 p.
  • Table of evidence levels. Cincinnati (OH): Cincinnati Children's Hospital Medical Center; 2008 Feb 29. 1 p.

Print copies: For information regarding the full-text guideline, print copies, or evidence-based practice support services contact the Cincinnati Children's Hospital Medical Center Health James M. Anderson Center for Health Systems Excellence at EBDMInfo@cchmc.org.

Patient Resources

None available

NGC Status

This NGC summary was completed by ECRI Institute on July 23, 2010.

Copyright Statement

This NGC summary is based on the original full-text guideline, which is subject to the following copyright restrictions:

Copies of this Cincinnati Children's Hospital Medical Center (CCHMC) External Web Site Policy Best Evidence Statement (BESt) are available online and may be distributed by any organization for the global purpose of improving child health outcomes. Examples of approved uses of the BESt include the following:

  • Copies may be provided to anyone involved in the organization's process for developing and implementing evidence based care.
  • Hyperlinks to the CCHMC website may be placed on the organization's website.
  • The BESt may be adopted or adapted for use within the organization, provided that CCHMC receives appropriate attribution on all written or electronic documents.
  • Copies may be provided to patients and the clinicians who manage their care.

Notification of CCHMC at EBDMInfo@cchmc.org for any BESt adopted, adapted, implemented or hyperlinked by the organization is appreciated.

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