Early Childhood (2-year) Outcomes Among Former VLBW From the ReDiMOM Trial

N/AEnrolling By InvitationNCT07702318

Rush University Medical Center275 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

275

Conditions

Preterm

Eligibility

Sex: ALLMax age: 3 Years

Medical Language ↔ Plain English

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

Locations (1)

Rush University

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Cognition

Cognitive index scores on Bayley Scales of Infant and Toddler Development-4th Edition at 20 months CA.

Time frame: 2 years

Adiposity

Adiposity measured by BIA

Time frame: 2 years

MOM duration

Duration of partial and/or exclusive MOM feedings through the first year of life using questionnaire.

Time frame: 1 year

Total costs

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

Time frame: 2 years

Language

Language index scores on Bayley Scales of Infant and Toddler Development-4th Edition at 20 months CA.

Time frame: 2 years

Motor

Motor index scores on Bayley Scales of Infant and Toddler Development-4th Edition at 20 months CA.

Time frame: 2 years