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โ† Trials
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BOND: Direct Breastfeeding to Enhance Maternal and Infant Health in Congenital Heart Disease

RecruitingNAAges 18 Years - anyAllCarelon Research
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Breastfeeding clinical practice guideline (CPG) for congenital heart disease (CHD)
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Where

17 sites
Phoenix Children's Hospital
Phoenix, United States
Children's Hospital of Los Angeles
Los Angeles, United States
Children's Hospital Colorado
Aurora, United States
Children's Healthcare of Atlanta
Atlanta, United States
Lurie Children's Hospital
Chicago, United States
Golisano Children's at UK
Lexington, United States
Boston Children's Hospital
Boston, United States
University of Michigan Health System, Ann Arbor
Ann Arbor, United States

โ€ฆand 9 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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