Preschool Outcomes of a Previous RCT - ReDiMOM (NCT04540575)

NCT07702357 | Enrolling By Invitation

• 2 other identifiers: 24091703R01HD119178
• Study Type: observational
• Target: 256
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate neurodevelopmental, health, and economic outcomes in preschool children born very preterm that participated in a randomized trial of an economic intervention designed to increase breastmilk feedings while they were in the neonatal intensive care unit.

Conditions

Preterm

Keywords

milk; cognition; health; executive function; quality of life; economic outcome; motor

Outcome Measures

Primary Outcomes (2)

• Cognition

  Cognitive outcome tested by the Wechsler Preschool and Primary Scale of Intelligence

  At 5-6 years of age

• Societal costs

  Societal costs will be defined as the sum of healthcare, education, family, and ReDiMOM intervention costs from birth to ages 6 years of age. Data will be obtained from ReDiMOM RCT intervention costs (ReDiMOM study database), healthcare costs (Rush data warehouse), early intervention therapies, Medicaid claims, and family costs (questionnaires).

  Through 6 years of age

Secondary Outcomes (8)

• Behavior

  Through 6 years of age

• Executive functioning

  Through 6 years of age

• Growth

  Through 6 years of age

• Health-related quality of life

  Through 6 years of age

• Adiposity

  Through 6 years of age

Study Arms (1)

ReDiMOM

Participants that were previously subjects in the ReDiMOM RCT (NCT04540575)

Other: This is a an observational prospective cohort study of a previous interventional trial (NCT04540575)

Interventions

This is a an observational prospective cohort study of a previous interventional trial (NCT04540575) OTHER

This is a an observational prospective cohort study

ReDiMOM

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All surviving children and their mothers who were enrolled in ReDiMOM RCT will be offered enrollment into this prospective observational study.

You may qualify if:

• Child was enrolled in ReDiMOM Child is alive

You may not qualify if:

• Child is not alive

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

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
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 14, 2026
• Study Start: March 6, 2026
• Primary Completion (Estimated): May 31, 2030
• Study Completion (Estimated): May 31, 2030
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Final submission and release of the study data will occur approximately 18 to 24 months following the end of data processing and creation of final data files or by the date of publication of the final study results, if publication occurs sooner. Study data deposited into Open Science Framework will be available in the repository for at least 5 years.
• Access Criteria: Study data and associated documentation will be made available to the research community free of charge through the Open Source Framework data repository (https://osf.io).

Locations

US (1)