Congenital Heart Disease (CHD)NCT07582848
BOND: Direct Breastfeeding to Enhance Maternal and Infant Health in Congenital Heart Disease
A study testing Breastfeeding clinical practice guideline (CPG) for congenital heart disease (CHD) in people with Congenital Heart Disease (CHD), run by Carelon Research at 17 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Heart Disease (CHD)
- What is being tested?
- Breastfeeding clinical practice guideline (CPG) for congenital heart disease (CHD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 17 sitesUnited States
- Study dates
- 22 Jul 2026to Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant individual carrying a fetus diagnosed with CHD or biological mother of an infant diagnosed with CHD in the neonatal period.
- Fetus or newborn with CHD anticipated to require cardiac surgery or transcatheter intervention in the first 30 days of life.
- 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.
- Willing to comply with protocol and provide written informed consent
Who cannot join
- Mother, fetal, or infant medical condition determined by a treating clinician to be contraindicative to study participation.
- 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.
- Mother with a moderate to severe intellectual disability or is otherwise unable to provide informed consent.
- Infant birthweight <3rd percentile for gestational age
- Infant gestational age < 36 weeks
- Infant with known genetic disorder likely to impact breastfeeding, such as trisomy 21 or cleft palate
- Medical condition or congenital anomaly that precludes safe direct breastfeeding for the infant as determined by investigator
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
United States17 sites, 17 recruiting
- Recruiting
University of Michigan Health System, Ann Arbor
Ann Arbor, Michigan, 48109
Principal Investigator
- Recruiting
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
Principal Investigator
- Not yet recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Principal Investigator
- Not yet recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Principal Investigator
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Principal Investigator
- Not yet recruiting
Lurie Children's Hospital
Chicago, Illinois, 60611
Principal Investigator
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Principal Investigator
- Not yet recruiting
Children's Mercy Hospital
Kansas City, Missouri, 64108
Principal Investigator
- Not yet recruiting
Golisano Children's at UK
Lexington, Kentucky, 40502
Principal Investigator
- Not yet recruiting
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Principal Investigator
- Recruiting
Le Bonheur Children's Hospital
Memphis, Tennessee, 38103
Principal Investigator
- Not yet recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Principal Investigator
- Not yet recruiting
Children's Hospital of New York
New York, New York, 10032
Principal Investigator
- Not yet recruiting
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Principal Investigator
- Not yet recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Principal Investigator
- Not yet recruiting
Primary Children's Medical Center
Salt Lake City, Utah, 84113
Principal Investigator
- Not yet recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Principal Investigator
About this study
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.
Read the 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.
- Conditions
- Congenital Heart Disease (CHD)
- Being tested
- Breastfeeding clinical practice guideline (CPG) for congenital heart disease (CHD)
- Keywords
- Direct breastfeeding, CHD, Infant neurodevelopment, Maternal Mental Health
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breastfeeding clinical practice guideline (CPG) for congenital heart disease (CHD)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding clinical practice guideline (CPG) | Experimental | 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. Receives: Other: Breastfeeding clinical practice guideline (CPG) for congenital heart disease (CHD) |
| Standard of Care | No intervention | This arm will receive standard of care with respect to breastfeeding at the clinical centers randomized to this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
direct breastfeeding at 4 months
any direct breastfeeding (yes/no)
Measured: 4 months
Secondary outcomes (8)
direct breastfeeding at 4 months in subpopulation of African Americans
any direct breastfeeding (yes/no) in subpopulation of African Americans
Measured: 4 months
Difference in Parental Stress Scale™ (PSS) from 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.
Measured: baseline to 4 months
Difference in Mother-Infant Bonding Scale (MIBS) from 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
Measured: baseline to 4 months
Weight for age Z-score < -3 at 4 months
WHO weight for age Z-score < -3
Measured: 4 months
Freedom from necrotizing enterocolitis (NEC) through 4 months of age
necrotizing enterocolitis
Measured: 4 months
Freedom from infection through 4 months of age
freedom from infection requiring hospital administration of antimicrobials for more than 48 hours
Measured: 4 months
Freedom from other major medical complications through 4 months of age
freedom from other major medical complications through 4 months of age
Measured: baseline to 4 months
Dysbiotic gut microbiome at 4 months of age
Dysbiotic index measured from gut microbiome
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start22 Jul 2026
- Primary completionJun 2029 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease (CHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participating sites will be randomized 1:1 between the intervention and control groups. Two randomization strata will be used: (1) center volume (higher vs. lower), and (2) current center breastfeeding rate in this population (higher vs. lower).
- Masking
- None (open label)
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carelon Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Mahle, MD, Study chair, Children's Healthcare of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582848
- Sponsor's protocol ID
- 20858 BOND Breastfeeding
- Status last verified
- Sep 2026
- First submitted
- 29 Apr 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified public use datasets with all study data will be created in accordance with NIH policy
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BOND: Direct Breastfeeding to Enhance Maternal and Infant Health in Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT07582848
- Acronym / sponsor ID
- 20858 BOND Breastfeeding
- Conditions
- Congenital Heart Disease (CHD)
- Keywords
- Direct breastfeeding, CHD, Infant neurodevelopment, Maternal Mental Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- Carelon ResearchUniversity, hospital or other
- Study start
- 22 Jul 2026 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participating sites will be randomized 1:1 between the intervention and control groups. Two randomization strata will be used: (1) center volume (higher vs. lower), and (2) current center breastfeeding rate in this population (higher vs. lower).
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding clinical practice guideline (CPG) | Experimental | 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. |
| Standard of Care | No intervention | –This arm will receive standard of care with respect to breastfeeding at the clinical centers randomized to this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pregnant individual carrying a fetus diagnosed with CHD or biological mother of an infant diagnosed with CHD in the neonatal period.
- Fetus or newborn with CHD anticipated to require cardiac surgery or transcatheter intervention in the first 30 days of life.
- 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.
- Willing to comply with protocol and provide written informed consent
Key exclusion criteria (7 listed)
- Mother, fetal, or infant medical condition determined by a treating clinician to be contraindicative to study participation.
- 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.
- Mother with a moderate to severe intellectual disability or is otherwise unable to provide informed consent.
- Infant birthweight <3rd percentile for gestational age
- Infant gestational age < 36 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Breastfeeding clinical practice guideline (CPG) |
Primary outcome
direct breastfeeding at 4 months
Time frame: 4 months
any direct breastfeeding (yes/no)
8 secondary outcomes
direct breastfeeding at 4 months in subpopulation of African Americans
Time frame: 4 months
Difference in Parental Stress Scale™ (PSS) from baseline to 4 months
Time frame: baseline to 4 months
Difference in Mother-Infant Bonding Scale (MIBS) from baseline to 4 months
Time frame: baseline to 4 months
Weight for age Z-score < -3 at 4 months
Time frame: 4 months
Freedom from necrotizing enterocolitis (NEC) through 4 months of age
Time frame: 4 months
Freedom from infection through 4 months of age
Time frame: 4 months
Freedom from other major medical complications through 4 months of age
Time frame: baseline to 4 months
Dysbiotic gut microbiome at 4 months of age
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified public use datasets with all study data will be created in accordance with NIH policy
Related trials for Congenital Heart Disease (CHD)
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
Active, not recruiting
Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With Critical CHD
Congenital Heart Disease, Executive Dysfunction
Not yet recruiting
UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease
Congenital Heart Disease, Cardiac Output
RecruitingPhase 1/2
Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids
Congenital Heart Disease (CHD)
Not yet recruiting
Starry-Sky Projection and Maternal Voice for Sleep After Pediatric Cardiac Surgery
Congenital Heart Disease (CHD), Postoperative Sleep
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William Mahle, MD study chair
Children's Healthcare of Atlanta
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breastfeeding clinical practice guideline (CPG) for congenital heart disease (CHD) in people with Congenital Heart Disease (CHD), run by Carelon Research at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Lynch, MPH (339-368-9294, stephanie.lynch@carelon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
direct breastfeeding at 4 months (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.