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
Recruiting
Apply to this trial

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

First listed
May 13, 2026
Start date
Jul 22, 2026
Status verified
Sep 2026
Primary completion
Jun 30, 2029
Completion
Aug 31, 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 (17)

FacilityCityStateZIPSite coordinators
Phoenix Children's HospitalPhoenixArizona85016
Principal Investigator
Children's Hospital of Los AngelesLos AngelesCalifornia90027
Principal Investigator
Children's Hospital ColoradoAuroraColorado80045
Principal Investigator
Children's Healthcare of AtlantaAtlantaGeorgia30329
Principal Investigator
Lurie Children's HospitalChicagoIllinois60611
Principal Investigator
Golisano Children's at UKLexingtonKentucky40502
Principal Investigator
Boston Children's HospitalBostonMassachusetts02115
Principal Investigator
University of Michigan Health System, Ann ArborAnn ArborMichigan48109
Principal Investigator
Children's Mercy HospitalKansas CityMissouri64108
Principal Investigator
Washington University School of MedicineSt LouisMissouri63110
Principal Investigator
Children's Hospital of New YorkNew YorkNew York10032
Principal Investigator
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Principal Investigator
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Principal Investigator
University of Pittsburgh Medical CenterPittsburghPennsylvania15213
Principal Investigator
Medical University of South CarolinaCharlestonSouth Carolina29425
Principal Investigator
Le Bonheur Children's HospitalMemphisTennessee38103
Principal Investigator
Primary Children's Medical CenterSalt Lake CityUtah84113
Principal Investigator

Find similar trials in Phoenix, AZ

By research site
Phoenix Children's Hospital· Phoenix, AZChildren's Hospital of Los Angeles· Los Angeles, CAChildren's Hospital Colorado· Aurora, COChildren's Healthcare of Atlanta· Atlanta, GALurie Children's Hospital· Chicago, ILGolisano Children's at UK· Lexington, KY

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