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.
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
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
Parallel
Breastfeeding clinical practice guideline (CPG) for congenital heart disease (CHD)
Other interventionThe 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.
direct breastfeeding at 4 months
any direct breastfeeding (yes/no)
direct breastfeeding at 4 months in subpopulation of African Americans
any direct breastfeeding (yes/no) in subpopulation of African Americans
Difference in Parental Stress Scale™ (PSS) from 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.
Difference in Mother-Infant Bonding Scale (MIBS) from 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
Weight for age Z-score < -3 at 4 months
WHO weight for age Z-score \< -3
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