Early Childhood Neurodevelopmental, Economic and Nutritional Outcomes Among Former Very Low Birth Weight Infants From the Reducing Disparity in Mother's Own Milk (ReDiMOM) Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Enrollment
- 275
- Locations
- 1
- Primary Endpoint
- Cognition
Study Overview
Brief Summary
The goal of this study is to determine the long-term outcomes associated with an economic intervention that was provided to encourage mother's of very premature infants to provide mother's own milk. This study will follow children after they are discharged from the Neonatal Intensive Care Unit, where their mothers received the economic intervention, out to age 2 years. This study will examine childhood outcomes at 2 years of age based on which group the mothers had been randomized into. This study will also determine the relationship between the total duration mother's own milk was received during the first year of life and early childhood outcomes at age 2 years in infants that were born very premature.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 3 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Completion of the ReDiMOM RCT
- •survival of infant to NICU discharge
Exclusion Criteria
- •Mother has participated in this study with a previous pregnancy
- •infant is enrolled in another study that impacts neurodevelopment or adiposity
- •in the neonatologist's opinion the infant is unlikely to survive
- •the mother is unable or unwilling to provide consent
Arms & Interventions
ReDiMOM
Participants were enrolled in ReDiMOM RCT
Outcomes
Primary Outcomes
Cognition
Time Frame: 2 years
Cognitive index scores on Bayley Scales of Infant and Toddler Development-4th Edition at 20 months CA.
Total costs
Time Frame: 2 years
Total costs at 20 months CA will be determined from the societal perspective and defined as the sum of ReDiMOM intervention, healthcare, EI and associated family costs from birth to 20 months CA. Detailed intervention costs for each infant are already collected for the original ReDiMOM RCT. Healthcare costs will be obtained from 5 sources: 1) ReDiMOM RCT prospective database, 2) self-report questionnaire to assess family healthcare costs, 3) Medicaid claims, 4) Illinois State Early Intervention Database, and 5) RUMC system-wide cost-account and billing systems
Language
Time Frame: 2 years
Language index scores on Bayley Scales of Infant and Toddler Development-4th Edition at 20 months CA.
Motor
Time Frame: 2 years
Motor index scores on Bayley Scales of Infant and Toddler Development-4th Edition at 20 months CA.
MOM duration
Time Frame: 1 year
Duration of partial and/or exclusive MOM feedings through the first year of life using questionnaire.
Adiposity
Time Frame: 2 years
Adiposity measured by BIA
Secondary Outcomes
No secondary outcomes reported