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NOT YET RECRUITING
NCT07582848
NA

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

Sponsor: Carelon Research

View on ClinicalTrials.gov

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

2026-04

Completion Date

2030-06

Last Updated

2026-05-13

Healthy Volunteers

No

Interventions

OTHER

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 (8)

Phoenix Children's Hospital

Phoenix, Arizona, 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

Children's Mercy Hospital

Kansas City, Missouri, United States

Children's Hospital of New York

New York, New York, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Le Bonheur Children's Hospital

Memphis, Tennessee, United States