BOND: Direct Breastfeeding to Enhance Maternal and Infant Health in Congenital Heart Disease (NCT07582848) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
BOND: Direct Breastfeeding to Enhance Maternal and Infant Health in Congenital Heart Disease
United States266 participantsStarted 2026-04
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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