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

Overview

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.

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.

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 pu

Primary outcome measures

• direct breastfeeding at 4 months [Time frame: 4 months]

Secondary outcome measures (8)

• direct breastfeeding at 4 months in subpopulation of African Americans [Time frame: 4 months]
• Difference in Parental Stress Scale™ (PSS) from baseline to 4 months [Time frame: baseline to 4 months]
• Difference in Mother-Infant Bonding Scale (MIBS) from baseline to 4 months [Time frame: baseline to 4 months]
• Weight for age Z-score < -3 at 4 months [Time frame: 4 months]
• Freedom from necrotizing enterocolitis (NEC) through 4 months of age [Time frame: 4 months]
• Freedom from infection through 4 months of age [Time frame: 4 months]
• Freedom from other major medical complications through 4 months of age [Time frame: baseline to 4 months]
• Dysbiotic gut microbiome at 4 months of age [Time frame: 4 months]

Eligibility criteria

Both mothers and infants are study participants.

Inclusion criteria

• Pregnant individual carrying a fetus diagnosed with CHD or biological mother of an infant diagnosed with CHD in the neonatal period.
• Fetus or newborn with CHD anticipated to require cardiac surgery or transcatheter intervention in the first 30 days of life.
• 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.
• Willing to comply with protocol and provide written informed consent

Exclusion criteria

• Mother, fetal, or infant medical condition determined by a treating clinician to be contraindicative to study participation.
• 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.
• Mother with a moderate to severe intellectual disability or is otherwise unable to provide informed consent.
• Infant birthweight <3rd percentile for gestational age
• Infant gestational age < 36 weeks
• Infant with known genetic disorder likely to impact breastfeeding, such as trisomy 21 or cleft palate
• Medical condition or congenital anomaly that precludes safe direct breastfeeding for the infant as determined by investigator

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 8 centers

• Phoenix Children's Hospital — Phoenix
• Children's Hospital Colorado — Aurora
• Children's Healthcare of Atlanta — Atlanta
• Lurie Children's Hospital — Chicago
• Children's Mercy Hospital — Kansas City
• Children's Hospital of New York — New York
• Medical University of South Carolina — Charleston
• Le Bonheur Children's Hospital — Memphis

Identifiers

NCT: NCT07582848 · 20858 BOND Breastfeeding

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗