266 Participants NeededMy employer runs this trial

Breastfeeding for Congenital Heart Disease

Recruiting at 16 trial locations
SP
JM
SL
Overseen ByStephanie Lynch, MPH
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

WM

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

My baby has a heart defect and will need surgery or a procedure within the first month of life.
Willing to comply with protocol and provide written informed consent
I was admitted to the ICU in my first week and need heart surgery or a procedure soon.
See 1 more

Exclusion Criteria

Mother, fetal, or infant medical condition determined by a treating clinician to be contraindicative to study participation
Infant gestational age < 36 weeks
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
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a multifaceted approach to enhance direct breastfeeding, including prenatal counseling, video viewing, and individual counseling by a registered lactation consultant

4 months
Weekly personal contact in-hospital, frequent post-discharge contact

Follow-up

Participants are monitored for maternal and infant health outcomes, including breastfeeding rates and medical complications

12 months

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

Group I: Breastfeeding clinical practice guideline (CPG)Experimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Carelon Research

Lead Sponsor

Trials
76
Recruited
125,000+

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.

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.