Direct breastfeeding to support babies with congenital heart disease and their families

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomised, adaptive platform trial that compares a direct breastfeeding enhancement program to standard care in infants with congenital heart disease. The goal is to increase the rate of direct breastfeeding at four months and to explore impacts on maternal mental health and child development, with follow-up through 12 months. Participating sites will be randomized to implement a breastfeeding clinical practice guideline for CHD or to continue conventional care. The study includes both mothers and infants and enrolls those with CHD requiring early intervention and ICU admission.

Why it matters

Who can join: the full rules

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

Where it's running

• Children's Healthcare of Atlanta
  Atlanta, Georgia, United States Recruiting
• University of Michigan Health System, Ann Arbor
  Ann Arbor, Michigan, United States Recruiting
• Cincinnati Children's Hospital Medical Center
  Cincinnati, Ohio, United States Recruiting
• Medical University of South Carolina
  Charleston, South Carolina, United States Recruiting
• Le Bonheur Children's Hospital
  Memphis, Tennessee, United States Recruiting
• Phoenix Children's Hospital
  Phoenix, Arizona, United States Not yet recruiting

Study contacts

• Study coordinator: Stephanie Lynch, MPH
• Email: stephanie.lynch@carelon.com
• Phone: 339-368-9294

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Improving transition of congenital heart disease care from pediatric to adult services

  This program will try a multi-step transfer process to reduce health declines in people with congenital heart disease who are waiting to see an adult specialist.

  Recruiting Ottawa Heart Institute Research Corporation · Ottawa, Ontario · NCT07585175

• HeartGPS: Prenatal mental health support for mothers of babies with CHD

  A pregnant person or mother of a baby with congenital heart disease will try a virtual mental health program (HeartGPS) in addition to standard care to see if it helps with well‑being and infant development.

  Recruiting at 5 sites Carelon Research · Phoenix, Arizona and 16 other locations · NCT07582861

• Music and Multisensory Interventions for Pain During Chest Tube Removal in Infants with Congenital Heart Disease

  This trial tests whether music or a multisensory mobile intervention can reduce pain and stabilize physiology during chest tube removal in 2- to 12-month-old infants with congenital heart disease.

  Recruiting Baskent University · Ankara · NCT07564882

• MedlyPeds: a smartphone app to monitor kids with heart disease

  This study tests whether the MedlyPeds app can help kids with heart conditions and their families stay informed and track symptoms remotely.

  Recruiting The Hospital for Sick Children · Toronto, Ontario · NCT07556185

• Fontan outcomes with low versus high lung blood flow in single‑ventricle hearts

  This project will test whether people with single‑ventricle congenital heart disease who have reduced versus increased pulmonary blood flow do better or worse after the Fontan operation.

  Recruiting National Cardiovascular Center Harapan Kita Hospital Indonesia · Jakarta, DKI Jakarta · NCT07535203

• Coughing exercises versus incentive spirometry for breathing recovery after pediatric heart surgery

  This study will test whether coughing exercises or incentive spirometry help children aged 6–18 recover their breathing and lung function after heart surgery.

  Recruiting at 4 sites University of Baghdad · Baghdad, Baghdad Governorate and 3 other locations · NCT07405333

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.