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

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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07702318

Enrollment

275

Registered

2026-07-14

Start date

2022-09-23

Completion date

2027-05-31

Last updated

2026-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm

Keywords

milk, very preterm, economic intervention

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 3 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Cognition	2 years	Cognitive index scores on Bayley Scales of Infant and Toddler Development-4th Edition at 20 months CA.
Adiposity	2 years	Adiposity measured by BIA
MOM duration	1 year	Duration of partial and/or exclusive MOM feedings through the first year of life using questionnaire.
Total costs	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	2 years	Language index scores on Bayley Scales of Infant and Toddler Development-4th Edition at 20 months CA.
Motor	2 years	Motor index scores on Bayley Scales of Infant and Toddler Development-4th Edition at 20 months CA.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAloka L Patel, MD

Rush University

PRINCIPAL_INVESTIGATORTricia Johnson, PhD