MedTrace Logo

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

NCT07582848 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

  • Congenital Heart Disease (CHD)

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.

Sponsors & Collaborators

  • Carelon Research

    lead OTHER

Principal Investigators

  • William Mahle, MD · Children's Healthcare of Atlanta

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2029-04-30
Completion
2030-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07582848 on ClinicalTrials.gov