Breastfeeding for Congenital Heart Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to help infants with congenital heart disease (CHD) by improving breastfeeding rates. It examines how direct breastfeeding affects the health and well-being of both the child and the parents. The trial includes two groups: one receives extra support and guidance for breastfeeding, including access to lactation consultants and breast pumps, while the other receives standard care. It is ideal for mothers expecting a baby diagnosed with CHD or those with a newborn needing heart surgery in the first month. Participants should be willing to follow the study guidelines and provide consent. As an unphased trial, this study offers a unique opportunity to contribute to understanding and improving care for infants with CHD.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What prior data suggests that this breastfeeding clinical practice guideline is safe for infants with congenital heart disease?
Research shows that breastfeeding can benefit babies with congenital heart disease (CHD). Although these babies often struggle with feeding and swallowing, studies indicate that direct breastfeeding can lead to better health outcomes. For example, babies with certain types of CHD who breastfeed tend to be healthier than those who do not.
Breastfeeding is a natural and generally well-tolerated practice. In this trial, researchers provide guidelines and support to help mothers breastfeed more effectively, including counseling and breast pumps. These are standard practices and are usually safe.
Overall, no evidence suggests that the breastfeeding guidelines in this study pose any safety risks to the babies or mothers involved.12345Why are researchers excited about this trial?
Researchers are excited about the Breastfeeding Clinical Practice Guideline (CPG) for congenital heart disease (CHD) because it introduces a comprehensive support system for breastfeeding, which is not typically part of standard care. This guideline includes prenatal counseling, personalized assistance from lactation consultants, and continuous support after leaving the hospital, which is more robust than usual care. By providing high-quality breast pumps and incentives to continue breastfeeding, this approach aims to improve the health of infants with CHD by ensuring they receive the benefits of breast milk. This could lead to better growth and development outcomes for these vulnerable babies.
What evidence suggests that this clinical practice guideline is effective for enhancing breastfeeding in infants with congenital heart disease?
This trial will compare a breastfeeding clinical practice guideline (CPG) with standard care for babies with congenital heart disease (CHD). Studies have shown that direct breastfeeding can improve health for babies with CHD. Research indicates that these babies often struggle with feeding and swallowing, but direct breastfeeding may alleviate these issues. Babies with CHD who are breastfed and receive human milk generally experience better health outcomes. Some studies also suggest that breastfeeding supports better growth and development in these babies. However, breastfeeding rates for babies with CHD are lower than those for healthy babies, highlighting the need for breastfeeding support in these cases.12356
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
Citations
Breastfeeding infants with CHD: an evidence summary ... - PMC
Infants with CHD are at risk for feeding and swallowing difficulties both pre- and postoperatively, with 18–56% of infants with CHD receiving a ...
BOND: Direct Breastfeeding to Enhance Maternal and ...
Infants with congenital heart disease have lower rates of breastfeeding than the healthy population. Direct breastfeeding may be particularly ...
Human Milk Feeding and Direct Breastfeeding Improve ...
Infants with single ventricle congenital heart disease in high‐HM and breastfeeding groups experienced multiple significantly better outcomes.
4.
experts.umn.edu
experts.umn.edu/en/publications/breastfeeding-infants-with-chd-an-evidence-summary-and-recommenda/Breastfeeding infants with CHD: an evidence summary and ...
Despite these benefits, human milk and breastfeeding rates for infants with CHD in high-resource countries are typically low, and there are no formal guidelines ...
Feeding the child with congenital heart disease: a narrative ...
This narrative review describes the nutritional considerations, obstacles and complications faced by children with CHD across their different phases of care.
Feeding Practices in Infants With Congenital Heart Disease
I'm just going to talk to you about some of our feeding practices here at Texas Children's and share some of the literature.
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