No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
266 (estimated)
Sponsor
Carelon Research · Other
Who this trial is looking for
This trial is looking for mothers and their infants who have been diagnosed with congenital heart disease. Participants will receive support to help increase direct breastfeeding.
Are You a Good Fit for This Trial?
You may be able to join if
I am pregnant with a fetus diagnosed with congenital heart disease.
I am the biological mother of a newborn diagnosed with congenital heart disease.
My fetus or newborn is expected to need heart surgery within the first month of life.
My infant was admitted to the ICU within the first week of life.
I am willing to follow the study rules and provide consent.
You may not be able to join if
I have a medical condition that prevents me from participating.
I have a severe untreated psychiatric condition or substance use disorder.
I have a moderate to severe intellectual disability.
My infant has a birth weight below the 3rd percentile for their age.
My infant was born before 36 weeks of gestation.
My infant has a genetic disorder that may affect breastfeeding.
My infant has a medical condition that makes breastfeeding unsafe.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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Status
Eligibility Criteria
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 interven…
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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