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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07702357

Enrollment

256

Registered

2026-07-14

Start date

2026-03-06

Completion date

2030-05-31

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, cognition, health, executive function, quality of life, economic outcome, motor

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.

Interventions

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

This is a an observational prospective cohort study

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to 6 Years

Healthy volunteers

Inclusion criteria

Child was enrolled in ReDiMOM Child is alive

Exclusion criteria

Child is not alive

Design outcomes

Primary

Measure	Time frame	Description
Cognition	At 5-6 years of age	Cognitive outcome tested by the Wechsler Preschool and Primary Scale of Intelligence
Societal costs	Through 6 years of age	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).

Secondary

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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAloka L Patel, MD

Rush University

PRINCIPAL_INVESTIGATORTricia Johnson, PhD