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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Carelon Research
Study ID
NCT07582848
Status
Not Yet Recruiting

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Conditions

  • Congenital Heart Disease (CHD)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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 Dates

Start date
Apr 30, 2026
Status verified
Feb 2026
Primary completion
Apr 30, 2029
Completion
Jun 30, 2030

Study Design

Enrollment
266 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Breastfeeding clinical practice guideline (CPG)
    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.
  • No Intervention: Standard of Care
    This arm will receive standard of care with respect to breastfeeding at the clinical centers randomized to this group.

Primary Outcome Measure

direct breastfeeding at 4 months [ Time Frame: 4 months ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Phoenix Children's HospitalPhoenixArizona85016
Principal Investigator
Children's Hospital ColoradoAuroraColorado80045
Principal Investigator
Children's Healthcare of AtlantaAtlantaGeorgia30329
Principal Investigator
Lurie Children's HospitalChicagoIllinois60611
Principal Investigator
Children's Mercy HospitalKansas CityMissouri64108
Principal Investigator
Children's Hospital of New YorkNew YorkNew York10032
Principal Investigator
Medical University of South CarolinaCharlestonSouth Carolina29425
Principal Investigator
Le Bonheur Children's HospitalMemphisTennessee38103
Principal Investigator

Find similar trials in Phoenix, AZ

By research site
Phoenix Children's Hospital· Phoenix, AZChildren's Hospital Colorado· Aurora, COChildren's Healthcare of Atlanta· Atlanta, GALurie Children's Hospital· Chicago, ILChildren's Mercy Hospital· Kansas City, MOChildren's Hospital of New York· New York, NY

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