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

8. september 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

266

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • Arizona
      • Phoenix, Arizona, Forente stater, 85016
        • Har ikke rekruttert ennå
        • Phoenix Children's Hospital
        • Ta kontakt med:
          • Principal Investigator
    • California
      • Los Angeles, California, Forente stater, 90027
        • Har ikke rekruttert ennå
        • Children's Hospital of Los Angeles
        • Ta kontakt med:
          • Principal Investigator
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • Har ikke rekruttert ennå
        • Children's Hospital Colorado
        • Ta kontakt med:
          • Principal Investigator
    • Georgia
      • Atlanta, Georgia, Forente stater, 30329
        • Rekruttering
        • Children's Healthcare of Atlanta
        • Ta kontakt med:
          • Principal Investigator
    • Illinois
      • Chicago, Illinois, Forente stater, 60611
        • Har ikke rekruttert ennå
        • Lurie Children's Hospital
        • Ta kontakt med:
          • Principal Investigator
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40502
        • Har ikke rekruttert ennå
        • Golisano Children's at UK
        • Ta kontakt med:
          • Principal Investigator
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02115
        • Har ikke rekruttert ennå
        • Boston Children's Hospital
        • Ta kontakt med:
          • Principal Investigator
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
        • Rekruttering
        • University of Michigan Health System, Ann Arbor
        • Ta kontakt med:
          • Principal Investigator
    • Missouri
      • Kansas City, Missouri, Forente stater, 64108
        • Har ikke rekruttert ennå
        • Children's Mercy Hospital
        • Ta kontakt med:
          • Principal Investigator
      • St Louis, Missouri, Forente stater, 63110
        • Har ikke rekruttert ennå
        • Washington University School of Medicine
        • Ta kontakt med:
          • Principal Investigator
    • New York
      • New York, New York, Forente stater, 10029
        • Har ikke rekruttert ennå
        • Icahn School of Medicine at Mount Sinai
        • Ta kontakt med:
          • Principal Investigator
      • New York, New York, Forente stater, 10032
        • Har ikke rekruttert ennå
        • Children's Hospital of New York
        • Ta kontakt med:
          • Principal Investigator
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45229
        • Rekruttering
        • Cincinnati Children's Hospital Medical Center
        • Ta kontakt med:
          • Principal Investigator
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forente stater, 15213
        • Har ikke rekruttert ennå
        • University of Pittsburgh Medical Center
        • Ta kontakt med:
          • Principal Investigator
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29425
        • Rekruttering
        • Medical University of South Carolina
        • Ta kontakt med:
          • Principal Investigator
    • Tennessee
      • Memphis, Tennessee, Forente stater, 38103
        • Rekruttering
        • Le Bonheur Children's Hospital
        • Ta kontakt med:
          • Principal Investigator
    • Utah
      • Salt Lake City, Utah, Forente stater, 84113
        • Har ikke rekruttert ennå
        • Primary Children's Medical Center
        • Ta kontakt med:
          • Principal Investigator

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: 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.
Ingen inngripen: Standard of Care
This arm will receive standard of care with respect to breastfeeding at the clinical centers randomized to this group.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
direct breastfeeding at 4 months
Tidsramme: 4 months
any direct breastfeeding (yes/no)
4 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
direct breastfeeding at 4 months in subpopulation of African Americans
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 4 months
WHO weight for age Z-score < -3
4 months
Freedom from necrotizing enterocolitis (NEC) through 4 months of age
Tidsramme: 4 months
necrotizing enterocolitis
4 months
Freedom from infection through 4 months of age
Tidsramme: 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
Tidsramme: 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
Tidsramme: 4 months
Dysbiotic index measured from gut microbiome
4 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Carelon Research

Etterforskere

  • Studiestol: William Mahle, MD, Children's Healthcare of Atlanta

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

22. juli 2026

Primær fullføring (Antatt)

1. juni 2029

Studiet fullført (Antatt)

1. august 2030

Datoer for studieregistrering

Først innsendt

29. april 2026

Først innsendt som oppfylte QC-kriteriene

6. mai 2026

Først lagt ut (Faktiske)

13. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 20858 BOND Breastfeeding

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

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.

Tilgangskriterier for IPD-deling

Creation of (free) login on PHN public website

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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