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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 32 days later Apr 2029 → Jun 2029
See other at-risk trials from Carelon Research

Record History

  1. Recruitment openedv2 Show 4 more changesShow less
    • Primary completion pushed from Apr 2029 to Jun 2029
    • Trial sites expanded: 8 → 17 locations
    • Study completion pushed from Jun 2030 to Aug 2030
    • Start date changed from estimate of Apr 2026 to Jul 22, 2026
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07582848
Lead Sponsor Carelon Research
Conditions
(from sponsor)		 Congenital Heart Disease (CHD)
Related terms Heart Defects, Congenital
Enrollment 266 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov