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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
266
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.
Phoenix Children's Hospital
Phoenix, Arizona, United States
NOT_YET_RECRUITINGChildren's Hospital of Los Angeles
Los Angeles, California, United States
NOT_YET_RECRUITINGChildren's Hospital Colorado
Aurora, Colorado, United States
NOT_YET_RECRUITINGChildren's Healthcare of Atlanta
Atlanta, Georgia, United States
RECRUITINGLurie Children's Hospital
Chicago, Illinois, United States
NOT_YET_RECRUITINGGolisano Children's at UK
Lexington, Kentucky, United States
NOT_YET_RECRUITINGBoston Children's Hospital
Boston, Massachusetts, United States
NOT_YET_RECRUITINGUniversity of Michigan Health System, Ann Arbor
Ann Arbor, Michigan, United States
RECRUITINGChildren's Mercy Hospital
Kansas City, Missouri, United States
NOT_YET_RECRUITINGWashington University School of Medicine
St Louis, Missouri, United States
NOT_YET_RECRUITING...and 7 more locations
direct breastfeeding at 4 months
any direct breastfeeding (yes/no)
Time frame: 4 months
direct breastfeeding at 4 months in subpopulation of African Americans
any direct breastfeeding (yes/no) in subpopulation of African Americans
Time frame: 4 months
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.
Time frame: baseline to 4 months
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
Time frame: baseline to 4 months
Weight for age Z-score < -3 at 4 months
WHO weight for age Z-score \< -3
Time frame: 4 months
Freedom from necrotizing enterocolitis (NEC) through 4 months of age
necrotizing enterocolitis
Time frame: 4 months
Freedom from infection through 4 months of age
freedom from infection requiring hospital administration of antimicrobials for more than 48 hours
Time frame: 4 months
Freedom from other major medical complications through 4 months of age
freedom from other major medical complications through 4 months of age
Time frame: baseline to 4 months
Dysbiotic gut microbiome at 4 months of age
Dysbiotic index measured from gut microbiome
Time frame: 4 months
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