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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Congenital Heart Disease (CHD)
• Intervention / Treatment: Other: Breastfeeding clinical practice guideline (CPG) for congenital heart disease (CHD)

Detailed Description

This is a domain of the Building Optimal Strategies to Enhance Parent and Infant Wellbeing in CHD (BOND) platform trail. BOND is a randomized, multifactorial, adaptive platform trial that seeks to optimize parent wellbeing and infant development following prenatal or neonatal diagnosis of congenital heart disease (CHD). The aim is to increase the proportion of infants with critical CHD who received direct breastfeeding at four months of age and to determine the impact of direct breastfeeding on maternal and infant health. Infants with congenital heart disease have lower rates of breastfeeding than the healthy population. Direct breastfeeding may be particularly beneficial in this population to reduce medical complications. In addition, direct breastfeeding may benefit maternal child bonding and enhance maternal mental health. Follow-up will continue through 12 months of infant age.

• Study Type: Interventional
• Enrollment (Estimated): 266
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susan Price, MPH; Phone Number: 859-940-1223; Email: susan.price@carelon.com
• Study Contact Backup: Name: Julie Miller, MPH; Phone Number: 7812274645; Email: julie.miller2@carelon.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Phoenix Children's Hospital
      • Contact: Principal Investigator
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado
      • Contact: Principal Investigator
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Children's Healthcare of Atlanta
      • Contact: Principal Investigator
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Lurie Children's Hospital
      • Contact: Principal Investigator
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital
      • Contact: Principal Investigator
  • New York
    • New York, New York, United States, 10032
      • Children's Hospital of New York
      • Contact: Principal Investigator
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
      • Contact: Principal Investigator
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • Le Bonheur Children's Hospital
      • Contact: Principal Investigator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Both mothers and infants are study participants.

Inclusion criteria:

1. Pregnant individual carrying a fetus diagnosed with CHD or biological mother of an infant diagnosed with CHD in the neonatal period.
2. Fetus or newborn with CHD anticipated to require cardiac surgery or transcatheter intervention in the first 30 days of life.
3. Admission to the ICU (either CICU or NICU) at participating center in 1st week of life and for whom cardiac surgical or transcatheter intervention is anticipated in the first 30 days of life.
4. Willing to comply with protocol and provide written informed consent

Exclusion Criteria:

1. Mother, fetal, or infant medical condition determined by a treating clinician to be contraindicative to study participation.
2. Mother with a severe, untreated psychiatric condition, substance use disorder, or other circumstances that, in the opinion of the investigator, would interfere with engagement with study tasks or safe participation in the trial.
3. Mother with a moderate to severe intellectual disability or is otherwise unable to provide informed consent.
4. Infant birthweight <3rd percentile for gestational age
5. Infant gestational age < 36 weeks
6. Infant with known genetic disorder likely to impact breastfeeding, such as trisomy 21 or cleft palate
7. Medical condition or congenital anomaly that precludes safe direct breastfeeding for the infant as determined by investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
No Intervention: Standard of Care; This arm will receive standard of care with respect to breastfeeding at the clinical centers randomized to this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
direct breastfeeding at 4 months	any direct breastfeeding (yes/no)	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
direct breastfeeding at 4 months in subpopulation of African Americans	any direct breastfeeding (yes/no) in subpopulation of African Americans	4 months
Difference in Parental Stress Scale™ (PSS) from baseline to 4 months	The Parental Stress Scale™ (PSS) is a measure of parental stress. The total score can range from 18 to 90, with higher scores indicating greater levels of parental stress and lower scores reflecting higher satisfaction with parenting.	baseline to 4 months
Difference in Mother-Infant Bonding Scale (MIBS) from baseline to 4 months	The Mother-Infant Bonding Scale (MIBS) is a measure of mother-infant bonding. The score ranges from 0-24, with higher scores indicating more significant bonding challenges	baseline to 4 months
Weight for age Z-score < -3 at 4 months	WHO weight for age Z-score < -3	4 months
Freedom from necrotizing enterocolitis (NEC) through 4 months of age	necrotizing enterocolitis	4 months
Freedom from infection through 4 months of age	freedom from infection requiring hospital administration of antimicrobials for more than 48 hours	4 months
Freedom from other major medical complications through 4 months of age	freedom from other major medical complications through 4 months of age	baseline to 4 months
Dysbiotic gut microbiome at 4 months of age	Dysbiotic index measured from gut microbiome	4 months

Collaborators and Investigators

• Sponsor: Carelon Research
• Investigators: Study Chair: William Mahle, MD, Children's Healthcare of Atlanta

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: April 29, 2026
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: CHD; Maternal Mental Health; Infant neurodevelopment; Direct breastfeeding
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Defects, Congenital; cytidylyl-3'-5'-guanosine
• Other Study ID Numbers: 20858 BOND Breastfeeding

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified public use datasets with all study data will be created in accordance with NIH policy
• IPD Sharing Time Frame: Data will be shared as soon as possible, but no later than the time of an associated publication or the end of the grant period, whichever comes first. Data will be available for as long as it is deemed useful for the larger research community, as directed by the PHN NHLBI project officers.
• IPD Sharing Access Criteria: Creation of (free) login on PHN public website
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No