Menu
Enrolling by invitation NCT07702318

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

Observational Preterm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Preterm. Basic parameters: up to 3 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Cognition [Time frame: 2 years]
  • Adiposity [Time frame: 2 years]
  • MOM duration [Time frame: 1 year]
  • Total costs [Time frame: 2 years]
  • Language [Time frame: 2 years]
  • Motor [Time frame: 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Rush University — Chicago

Publications

  • 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

Identifiers

NCT: NCT07702318 · 20102003 · R01HD107348

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗