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

NCT07702318 | Enrolling By Invitation

• 2 other identifiers: 20102003R01HD107348
• Study Type: observational
• Target: 275
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm

Keywords

milk; very preterm; economic intervention

Outcome Measures

Primary Outcomes (6)

• Cognition

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

  2 years

• Adiposity

  Adiposity measured by BIA

  2 years

• MOM duration

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

  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

  2 years

• Language

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

  2 years

• Motor

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

  2 years

Study Arms (1)

ReDiMOM

Participants were enrolled in ReDiMOM RCT

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Participants were cared for in the Rush NICU in Chicago, IL and participated in the ReDiMOM randomized controlled trial.

You may qualify if:

• Completion of the ReDiMOM RCT
• survival of infant to NICU discharge

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Rush University

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• Kraemer MK, Johnson TJ, Bell KA, Mulcahy DC, Cerwinske LA, Patra K, Appelhans BM, David J, Belfort MB, Diep QM, Patel AL. Neonatal steroid exposure and body composition in preterm infants at discharge. Pediatr Res. 2026 Feb 27:10.1038/s41390-026-04796-w. doi: 10.1038/s41390-026-04796-w. Online ahead of print.

  PMID: 41748748 RESULT

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Aloka L Patel, MD

  Rush University

  PRINCIPAL INVESTIGATOR

• Tricia Johnson, PhD

  Rush University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 14, 2026
• Study Start: September 23, 2022
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: An independent review committee and the principal investigators will review requests for data no sooner than 2 to 5 years after publication of final results.

Locations

US (1)