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

Starting soon · Not applicable

Conditions studied: Congenital Heart Disease (CHD)

In brief

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 facts

Study ID

NCT07582848

Run by

Carelon Research

People needed

266

Starts

2026-04-01

Expected to finish

2030-06-01

Last updated by the study team

2026-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Lurie Children's Hospital — Chicago, Illinois, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• Children's Hospital of New York — New York, New York, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Le Bonheur Children's Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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