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BOND: Direct Breastfeeding to Enhance Maternal and Infant Health in Congenital Heart Disease
Sponsor: Carelon Research
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
266
Start Date
2026-07-22
Completion Date
2030-08
Last Updated
2026-09-10
Healthy Volunteers
No
Conditions
Interventions
Breastfeeding clinical practice guideline (CPG) for congenital heart disease (CHD)
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.
Locations (17)
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