BOND: Direct Breastfeeding to Enhance Maternal and Infant Health in Congenital Heart Disease
6. maj 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
266
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Susan Price, MPH
- Telefonnummer: 859-940-1223
- E-mail: susan.price@carelon.com
Undersøgelse Kontakt Backup
- Navn: Julie Miller, MPH
- Telefonnummer: 7812274645
- E-mail: julie.miller2@carelon.com
Studiesteder
-
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Arizona
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Phoenix, Arizona, Forenede Stater, 85016
- Phoenix Children's Hospital
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Kontakt:
- Principal Investigator
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- Children's Hospital Colorado
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Kontakt:
- Principal Investigator
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Georgia
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Atlanta, Georgia, Forenede Stater, 30329
- Children's Healthcare of Atlanta
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Kontakt:
- Principal Investigator
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Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Lurie Children's Hospital
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Kontakt:
- Principal Investigator
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Missouri
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Kansas City, Missouri, Forenede Stater, 64108
- Children's Mercy Hospital
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Kontakt:
- Principal Investigator
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New York
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New York, New York, Forenede Stater, 10032
- Children's Hospital of New York
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Kontakt:
- Principal Investigator
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
- Medical University of South Carolina
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Kontakt:
- Principal Investigator
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Tennessee
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Memphis, Tennessee, Forenede Stater, 38103
- Le Bonheur Children's Hospital
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Kontakt:
- Principal Investigator
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
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.
|
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Ingen indgriben: Standard of Care
This arm will receive standard of care with respect to breastfeeding at the clinical centers randomized to this group.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
direct breastfeeding at 4 months
Tidsramme: 4 months
|
any direct breastfeeding (yes/no)
|
4 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
|
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Weight for age Z-score < -3 at 4 months
Tidsramme: 4 months
|
WHO weight for age Z-score < -3
|
4 months
|
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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
|
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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
|
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Dysbiotic gut microbiome at 4 months of age
Tidsramme: 4 months
|
Dysbiotic index measured from gut microbiome
|
4 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: William Mahle, MD, Children's Healthcare of Atlanta
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. april 2026
Primær færdiggørelse (Anslået)
1. april 2029
Studieafslutning (Anslået)
1. juni 2030
Datoer for studieregistrering
Først indsendt
29. april 2026
Først indsendt, der opfyldte QC-kriterier
6. maj 2026
Først opslået (Faktiske)
13. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. maj 2026
Sidst verificeret
1. februar 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20858 BOND Breastfeeding
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (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.
IPD-delingsadgangskriterier
Creation of (free) login on PHN public website
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
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