BOND: Direct Breastfeeding to Enhance Maternal and Infant Health in Congenital Heart Disease

September 8, 2026 updated by: Carelon Research
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a domain of the Building Optimal Strategies to Enhance Parent and Infant Wellbeing in CHD (BOND) platform trail. BOND is a randomized, multifactorial, adaptive platform trial that seeks to optimize parent wellbeing and infant development following prenatal or neonatal diagnosis of congenital heart disease (CHD). The aim is to increase the proportion of infants with critical CHD who received direct breastfeeding at four months of age and to determine the impact of direct breastfeeding on maternal and infant health. Infants with congenital heart disease have lower rates of breastfeeding than the healthy population. Direct breastfeeding may be particularly beneficial in this population to reduce medical complications. In addition, direct breastfeeding may benefit maternal child bonding and enhance maternal mental health. Follow-up will continue through 12 months of infant age.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
266

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Not yet recruiting
        • Phoenix Children's Hospital
        • Contact:
          • Principal Investigator
    • California
      • Los Angeles, California, United States, 90027
        • Not yet recruiting
        • Children's Hospital of Los Angeles
        • Contact:
          • Principal Investigator
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Not yet recruiting
        • Children's Hospital Colorado
        • Contact:
          • Principal Investigator
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Recruiting
        • Children's Healthcare of Atlanta
        • Contact:
          • Principal Investigator
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Not yet recruiting
        • Lurie Children's Hospital
        • Contact:
          • Principal Investigator
    • Kentucky
      • Lexington, Kentucky, United States, 40502
        • Not yet recruiting
        • Golisano Children's at UK
        • Contact:
          • Principal Investigator
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Not yet recruiting
        • Boston Children's Hospital
        • Contact:
          • Principal Investigator
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Health System, Ann Arbor
        • Contact:
          • Principal Investigator
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Not yet recruiting
        • Children's Mercy Hospital
        • Contact:
          • Principal Investigator
      • St Louis, Missouri, United States, 63110
        • Not yet recruiting
        • Washington University School of Medicine
        • Contact:
          • Principal Investigator
    • New York
      • New York, New York, United States, 10029
        • Not yet recruiting
        • Icahn School of Medicine at Mount Sinai
        • Contact:
          • Principal Investigator
      • New York, New York, United States, 10032
        • Not yet recruiting
        • Children's Hospital of New York
        • Contact:
          • Principal Investigator
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
          • Principal Investigator
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Not yet recruiting
        • University of Pittsburgh Medical Center
        • Contact:
          • Principal Investigator
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
          • Principal Investigator
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • Recruiting
        • Le Bonheur Children's Hospital
        • Contact:
          • Principal Investigator
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • Not yet recruiting
        • Primary Children's Medical Center
        • Contact:
          • Principal Investigator

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: 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.
No Intervention: Standard of Care
This arm will receive standard of care with respect to breastfeeding at the clinical centers randomized to this group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
direct breastfeeding at 4 months
Time Frame: 4 months
any direct breastfeeding (yes/no)
4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
direct breastfeeding at 4 months in subpopulation of African Americans
Time Frame: 4 months
any direct breastfeeding (yes/no) in subpopulation of African Americans
4 months
Difference in Parental Stress Scale™ (PSS) from baseline to 4 months
Time Frame: baseline to 4 months
The Parental Stress Scale™ (PSS) is a measure of parental stress. The total score can range from 18 to 90, with higher scores indicating greater levels of parental stress and lower scores reflecting higher satisfaction with parenting.
baseline to 4 months
Difference in Mother-Infant Bonding Scale (MIBS) from baseline to 4 months
Time Frame: baseline to 4 months
The Mother-Infant Bonding Scale (MIBS) is a measure of mother-infant bonding. The score ranges from 0-24, with higher scores indicating more significant bonding challenges
baseline to 4 months
Weight for age Z-score < -3 at 4 months
Time Frame: 4 months
WHO weight for age Z-score < -3
4 months
Freedom from necrotizing enterocolitis (NEC) through 4 months of age
Time Frame: 4 months
necrotizing enterocolitis
4 months
Freedom from infection through 4 months of age
Time Frame: 4 months
freedom from infection requiring hospital administration of antimicrobials for more than 48 hours
4 months
Freedom from other major medical complications through 4 months of age
Time Frame: baseline to 4 months
freedom from other major medical complications through 4 months of age
baseline to 4 months
Dysbiotic gut microbiome at 4 months of age
Time Frame: 4 months
Dysbiotic index measured from gut microbiome
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Carelon Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: William Mahle, MD, Children's Healthcare of Atlanta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 22, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20858 BOND Breastfeeding

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified public use datasets with all study data will be created in accordance with NIH policy

IPD Sharing Time Frame

Data will be shared as soon as possible, but no later than the time of an associated publication or the end of the grant period, whichever comes first. Data will be available for as long as it is deemed useful for the larger research community, as directed by the PHN NHLBI project officers.

IPD Sharing Access Criteria

Creation of (free) login on PHN public website

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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