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NCT Number: NCT07582848

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

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.

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Key information

Conditions

Congenital Heart Disease (CHD) Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Phoenix Children's Hospital, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Both mothers and infants are study participants.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. direct breastfeeding at 4 months

    Time frame: 4 months

    any direct breastfeeding (yes/no)

Secondary outcomes

  1. direct breastfeeding at 4 months in subpopulation of African Americans

    Time frame: 4 months

    any direct breastfeeding (yes/no) in subpopulation of African Americans

  2. 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.

  3. 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

  4. Weight for age Z-score < -3 at 4 months

    Time frame: 4 months

    WHO weight for age Z-score < -3

  5. Freedom from necrotizing enterocolitis (NEC) through 4 months of age

    Time frame: 4 months

    necrotizing enterocolitis

  6. 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

  7. 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

  8. Dysbiotic gut microbiome at 4 months of age

    Time frame: 4 months

    Dysbiotic index measured from gut microbiome

Study contacts

Contact information is provided by the study sponsor or research team.

Julie Miller, MPH

CONTACT

[email protected]

7812274645

Susan Price, MPH

CONTACT

[email protected]

859-940-1223

Sponsors and collaborators

Lead sponsor

Carelon Research

Other

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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