RECRUITING Not applicable ClinicalTrials.gov

BOND: Direct Breastfeeding to Enhance Maternal and Infant Health in Congenital Heart Disease

Sponsor: Carelon Research • ClinicalTrials.gov ID: NCT07582848

Registry updated: 2026-09-10

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Description

The primary objective of this study is to enhance the rates of direct breast feeding (DBF) among infants with congenital heart disease (CHD), and to gain insights into the implications of DBF on key metrics of child and parent well-being. A multicenter parallel cluster platform design will be employed. The intervention will be a multifaceted approach to enhance direct breastfeeding. Participating sites will be randomized into either intervention (strategies to enhance direct breastfeeding) or conventional care.

Interventions

Breastfeeding clinical practice guideline (CPG) for congenital heart disease (CHD) (Other)
The clinical practice guideline (CPG) intervention will be developed by the clinical centers randomized to this arm. The intervention plan will likely include: 1) prenatal counseling; 2) viewing a video on breastfeeding CHD infants; 3) individual counseling by a registered lactation consultant (RLC), 4) weekly personal contact in-hospital by the RLC, 5) frequent contact post discharge by the RLC through the first year or until breastfeeding is discontinued, 6) provision of high-quality breast pumps, 7) incentive to continue with pumping breastmilk or direct breastfeeding.

Eligibility criteria

Both mothers and infants are study participants. Inclusion criteria: 1. Pregnant individual carrying a fetus diagnosed with CHD or biological mother of an infant diagnosed with CHD in the neonatal period. 2. Fetus or newborn with CHD anticipated to require cardiac surgery or transcatheter intervention in the first 30 days of life. 3. Admission to the ICU (either CICU or NICU) at participating center in 1st week of life and for whom cardiac surgical or transcatheter intervention is anticipated in the first 30 days of life. 4. Willing to comply with protocol and provide written informed consent Exclusion Criteria: 1. Mother, fetal, or infant medical condition determined by a treating clinician to be contraindicative to study participation. 2. Mother with a severe, untreated psychiatric condition, substance use disorder, or other circumstances that, in the opinion of the investigator, would interfere with engagement with study tasks or safe participation in the trial. 3. Mother with a moderate to severe intellectual disability or is otherwise unable to provide informed consent. 4. Infant birthweight \<3rd percentile for gestational age 5. Infant gestational age \< 36 weeks 6. Infant with known genetic disorder likely to impact breastfeeding, such as trisomy 21 or cleft palate 7. Medical condition or congenital anomaly that precludes safe direct breastfeeding for the infant as determined by investigator

Conditions

Congenital Heart Disease (CHD)

Locations

Phoenix Children's Hospital — Phoenix, Arizona, United States
Children's Hospital of Los Angeles — Los Angeles, California, United States
Children's Hospital Colorado — Aurora, Colorado, United States
Children's Healthcare of Atlanta — Atlanta, Georgia, United States
Lurie Children's Hospital — Chicago, Illinois, United States
Golisano Children's at UK — Lexington, Kentucky, United States
Boston Children's Hospital — Boston, Massachusetts, United States
University of Michigan Health System, Ann Arbor — Ann Arbor, Michigan, United States
Children's Mercy Hospital — Kansas City, Missouri, United States
Washington University School of Medicine — St Louis, Missouri, United States
Icahn School of Medicine at Mount Sinai — New York, New York, United States
Children's Hospital of New York — New York, New York, United States
Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
Medical University of South Carolina — Charleston, South Carolina, United States
Le Bonheur Children's Hospital — Memphis, Tennessee, United States
Primary Children's Medical Center — Salt Lake City, Utah, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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