2023-14184. Supplemental Evidence and Data Request on Breastfeeding and Health Outcomes for Infants and Children

AGENCY:

Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION:

Request for supplemental evidence and data submissions.

SUMMARY:

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Breastfeeding and Health Outcomes for Infants and Children, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.

DATES:

Submission Deadline on or before August 4, 2023.

ADDRESSES:

Email submissions: [e-mail].

Print submissions:

Mailing Address: Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857.

Shipping Address (FedEx, UPS, etc.): Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Kelly Carper, Telephone: [phone] or Email: [e-mail].

SUPPLEMENTARY INFORMATION:

The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for Breastfeeding and Health Outcomes for Infants and Children. AHRQ is conducting this systematic review pursuant to section 902 of the Public Health Service Act, 42 U.S.C. 299a.

The EPC Program is dedicated to identifying as many studies as possible that are relevant to the questions for each of its reviews. In order to do so, we are supplementing the usual manual and electronic database searches of the literature by requesting information from the public ( e.g., details of studies conducted). We are looking for studies that report on Breastfeeding and Health Outcomes for Infants and Children, including those that describe adverse events. The entire research protocol is available online at: https://effectivehealthcare.ahrq.gov/​products/​breastfeeding-health-outcomes/​protocol.

This is to notify the public that the EPC Program would find the following information on Breastfeeding and Health Outcomes for Infants and Children helpful:

A list of completed studies that your organization has sponsored for this indication. In the list, please indicate whether results are available on ClinicalTrials.gov along with the ClinicalTrials.gov trial number.

For completed studies that do not have results on ClinicalTrials.gov, a summary, including the following elements: study number, study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, primary and secondary outcomes, baseline characteristics, number of patients screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, effectiveness/efficacy, and safety results.

A list of ongoing studies that your organization has sponsored for this indication. In the list, please provide the ClinicalTrials.gov trial number or, if the trial is not registered, the protocol for the study including a study number, the study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, and primary and secondary outcomes.

Description of whether the above studies constitute ALL Phase II and above clinical trials sponsored by your organization for this indication and an index outlining the relevant information in each submitted file.

Your contribution is very beneficial to the Program. Materials submitted must be publicly available or able to be made public. Materials that are considered confidential; marketing materials; study types not included in the review; or information on indications not included in the review cannot be used by the EPC Program. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter.

The draft of this review will be posted on AHRQ's EPC Program website and available for public comment for a period of 4 weeks. If you would like to be notified when the draft is posted, please sign up for the email list at: https://www.effectivehealthcare.ahrq.gov/​email-updates.

The systematic review will answer the following questions. This information is provided as background. AHRQ is not requesting that the public provide answers to these questions.

Key Questions (KQ)

This review will be guided by one Key Question (KQ 1) that addresses the infant and child health outcomes associated with breastfeeding and consuming human milk. One sub-KQ (KQ 1a) addresses variation in the associations by important variables related to breastfeeding and human milk consumption.

1. What is the association between breastfeeding/human milk consumption and health outcomes among infants and children?

a. How do these associations vary by intensity (including exclusivity), duration, and mode of feeding, and by source of human milk?

Population, Intervention, Comparator, Outcome, Timing, Setting/Study Design (PICOTS)

PICOTS	Inclusion	Exclusion
Populations	Full term infants (≥37 and 0/7 weeks gestation)	Studies exclusively among:
	• Preterm (gestational age <37 weeks) infants a
	• Low birth weight (<2500 grams) or small for gestational age infants
	• Women with medical conditions contraindicated for breastfeeding ( e.g., breast cancer, HIV)
Exposures	Any exposure to human milk, including feeding at the breast; consuming expressed human milk; or a combination	Application of human milk to skin
Comparators	• No exposure to human milk	All other comparisons; no comparison.
	• Less intensive exposure ( e.g., mixed feeding or commercial milk formula consumption vs. exclusive consumption; lower proportion of feedings that are human milk)
	• Shorter duration of exposure
	• Different mechanism of exposure ( e.g., feeding at the breast [direct breastfeeding] vs. feeding expressed human milk)
	• Different source of human milk ( e.g., milk from lactating parent vs. milk from donor)
Outcomes b	Health outcomes observed at any point in the life course, specifically:	Any other outcome not specified, including maternal health outcomes.
	• Allergies, specifically:
	○ Atopic dermatitis
	○ Allergic rhinitis
	○ Food allergies
	• Asthma
	• Celiac disease
	• Cognitive development ( e.g., measures of IQ and other cognitive development measures)
	• Childhood cancer
	• Cardiovascular disease outcomes, specifically:
	○ Blood lipid levels, hyperlipidemia
	○ Blood pressure, elevated blood pressure
	○ Arterial stiffness, intima-media thickness, atherosclerosis
	○ Metabolic syndrome
	○ Incidence and prevalence of CVD
	○ CVD-related mortality
	• Diabetes, specifically
	○ Type I
	○ Type II
	• Infectious diseases, specifically:
	○ Otitis media
	○ Diarrhea/GI infection
	○ Upper and lower respiratory tract infections including COVID–19
	• Oral health outcomes, specifically:
	○ Dental caries
	○ Malocclusions
	• Sudden infant death syndrome/sudden unexpected infant death
	• Infant mortality
	• Inflammatory bowel disease
	• Weight-related outcomes, specifically:
	○ Weight gain velocity (birth to 24 months)
	○ Obesity
Country setting	Studies conducted in a more developed country, defined as “very high” on the 2021 human development index per the United Nations Development Programme 44	Studies conducted in other countries.
Study designs	• Existing systematic reviews c	All other designs, including:
	• Observational studies comparing health outcomes among 2 or more groups with different exposures to human milk, including cohort and case-control d studies and studies with observational follow-up of health outcomes from randomized or non-randomized clinical trials of breastfeeding support interventions	• Studies of breastfeeding support interventions without observational follow-up of health outcomes. • Studies with no comparison groups. • Cross-sectional studies.e • Case series.
Publication language	Studies published in English	Studies published in languages other than English.
Abbreviations: ADHD = attention deficit hyperactivity disorder; ASD = autism spectrum disorder; COVID–19 = coronavirus disease 2019; GI = gastrointestinal; HIV = human immunodeficiency virus; NICU = neonatal intensive care unit.
a  The full report will contextually consider the unique feeding needs of this population and will discuss what we know about the association between breastfeeding and health outcomes for preterm infants. This evidence will not be systematically reviewed.
b  The full report will contextually discuss potentially harmful unintended consequences related to breastfeeding such as excessive weight loss, hyperbilirubinemia, and hypoglycemia. This evidence will not be systematically reviewed
c  Well-conducted systematic review, with or without meta-analysis, that aligns with these PICOTS criteria and is not rated as “critically low” according to systematic review credibility criteria using AMSTAR 2.45
d  Case-control studies will be considered only in cases in which the outcome is rare (<1/1000) and/or this is the only evidence available for that particular outcome.
e  Cross-sectional studies will be excluded except in cases in which the study compares outcomes between twins or siblings with different exposures.

Dated: June 29, 2023.

Marquita Cullom,

Associate Director.