Preschool Outcomes of a Previous RCT - ReDiMOM (NCT04540575)

Neurodevelopmental, Health, and Economic Outcomes at Preschool Age in Former Very Preterm Infants Randomized to An Economic Intervention to Support Mother's Own Milk

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Preterm
• Intervention / Treatment: Other: This is a an observational prospective cohort study of a previous interventional trial (NCT04540575)

• Study Type: Observational
• Enrollment (Estimated): 256

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

Child was enrolled in ReDiMOM Child is alive

Exclusion Criteria:

Child is not alive

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); This is a an observational prospective cohort study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavior	Behavior will be evaluated with the Behavioral Assessment System for Children-Third Edition (BASC-3)	Through 6 years of age
Executive functioning	Executive functioning will be evaluated with the Behavioral Assessment System for Children-Third Edition (BASC-3)	Through 6 years of age
Growth	Anthropometric measurements taken annually	Through 6 years of age
Health-related quality of life	Health-related quality of life will be measured via the EQ-5D-Y	Through 6 years of age
Adiposity	Adiposity will be measured annually using Bioelectrical Impedance Analysis (BIA)	Through 6 years of age
Blood pressure	Measured annually	Through 6 years of age
Respiratory Health	History of recurrent wheeze or asthma will be collected via questionnaires	Through 6 years of age
Motor function	Motor function will be assessed with the Movement Assessment Battery for Children, Third Edition (MABC-3)	Through 6 years of age

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Aloka L Patel, MD, Rush University; Principal Investigator: Tricia Johnson, PhD, Rush University

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2026
• Primary Completion (Estimated): May 31, 2030
• Study Completion (Estimated): May 31, 2030

Study Registration Dates

• First Submitted: June 26, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: health; quality of life; cognition; executive function; milk; motor; economic outcome
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: 24091703; R01HD119178 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data that are aggregated to the analytic unit of analysis (e.g., subject, year) will be made available via Open Science Framework.
• IPD Sharing 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.
• IPD Sharing 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).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No