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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breastfeeding clinical practice guideline (CPG) | Experimental | 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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| Standard of Care | No Intervention | This arm will receive standard of care with respect to breastfeeding at the clinical centers randomized to this group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breastfeeding clinical practice guideline (CPG) for congenital heart disease (CHD) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| direct breastfeeding at 4 months | any direct breastfeeding (yes/no) | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| direct breastfeeding at 4 months in subpopulation of African Americans | any direct breastfeeding (yes/no) in subpopulation of African Americans | 4 months |
| Difference in Parental Stress Scale⢠(PSS) from baseline to 4 months |
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Both mothers and infants are study participants.
Inclusion criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susan Price, MPH | Contact | 859-940-1223 | susan.price@carelon.com | |
| Julie Miller, MPH | Contact | 7812274645 | julie.miller2@carelon.com |
| Name | Affiliation | Role |
|---|---|---|
| William Mahle, MD | Children's Healthcare of Atlanta | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | United States |
De-identified public use datasets with all study data will be created in accordance with NIH policy
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.
Creation of (free) login on PHN public website
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Participating sites will be randomized 1:1 between the intervention and control groups. Two randomization strata will be used: (1) center volume (higher vs. lower), and (2) current center breastfeeding rate in this population (higher vs. lower).
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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 | 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 |
| Weight for age Z-score < -3 at 4 months | WHO weight for age Z-score < -3 | 4 months |
| Freedom from necrotizing enterocolitis (NEC) through 4 months of age | necrotizing enterocolitis | 4 months |
| Freedom from infection through 4 months of age | freedom from infection requiring hospital administration of antimicrobials for more than 48 hours | 4 months |
| Freedom from other major medical complications through 4 months of age | freedom from other major medical complications through 4 months of age | baseline to 4 months |
| Dysbiotic gut microbiome at 4 months of age | Dysbiotic index measured from gut microbiome | 4 months |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
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| Children's Healthcare of Atlanta | Atlanta | Georgia | 30329 | United States |
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| Lurie Children's Hospital | Chicago | Illinois | 60611 | United States |
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| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
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| Children's Hospital of New York | New York | New York | 10032 | United States |
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| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| Le Bonheur Children's Hospital | Memphis | Tennessee | 38103 | United States |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| C015772 | cytidylyl-3'-5'-guanosine |
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