Recruiting

Direct Breastfeeding

Sponsor:

Carelon Research

Code:

NCT07582848

Conditions

Congenital Heart Disease (CHD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Breastfeeding clinical practice guideline (CPG) for congenital heart disease (CHD)

Study Details

Brief 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.

Conditions

Congenital Heart Disease (CHD)

Study ID

NCT07582848

Start date

Jul 22, 2026

Status verified date

Sep, 2026

Completion date

Aug, 2030

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

266 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Breastfeeding clinical practice guideline (CPG)

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.

no intervention: Standard of Care

This arm will receive standard of care with respect to breastfeeding at the clinical centers randomized to this group.

Interventions

Breastfeeding clinical practice guideline (CPG) for congenital heart disease (CHD)

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.

Primary outcome measure

  • direct breastfeeding at 4 months [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Locations

Children's Healthcare of Atlanta

Recruiting

Atlanta, Georgia, United States, 30329

University of Michigan Health System, Ann Arbor

Recruiting

Ann Arbor, Michigan, United States, 48109

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Le Bonheur Children's Hospital

Recruiting

Memphis, Tennessee, United States, 38103

More Information

Sponsor

Carelon Research

Last update posted

Sep 10, 2026

Last verified

Sep, 2026

Keywords

  • Direct breastfeeding
  • CHD
  • Infant neurodevelopment
  • Maternal Mental Health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Carelon Research on 2026-09-10.