Breastfeeding for Congenital Heart Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
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 Is on the Research Team?
William Mahle, MD
Principal Investigator
Children's Healthcare of Atlanta
Are You a Good Fit for This Trial?
This trial is for mothers and their newborns diagnosed with congenital heart disease who are expected to need heart surgery or a procedure within the first month of life. Both must be admitted to an ICU in the baby's first week, and participants must agree to follow study procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive a multifaceted approach to enhance direct breastfeeding, including prenatal counseling, video viewing, and individual counseling by a registered lactation consultant
Follow-up
Participants are monitored for maternal and infant health outcomes, including breastfeeding rates and medical complications
What Are the Treatments Tested in This Trial?
Interventions
- Breastfeeding clinical practice guideline (CPG) for congenital heart disease (CHD)
Trial Overview
The study compares usual care versus special strategies designed to support direct breastfeeding among infants with congenital heart disease. Hospitals are randomly assigned either the new breastfeeding approach or standard care.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
This arm will receive standard of care with respect to breastfeeding at the clinical centers randomized to this group.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Carelon Research
Lead Sponsor
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