Preschool Outcomes of a Previous RCT - ReDiMOM (NCT04540575)
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
- The protocol lists: This is a an observational prospective cohort study of a previous interventional trial (NCT04540575).
- Who it may be relevant to
- Registry conditions: Preterm. Basic parameters: 2 years — 6 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 →
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Official title
Neurodevelopmental, Health, and Economic Outcomes at Preschool Age in Former Very Preterm Infants Randomized to An Economic Intervention to Support Mother's Own Milk
Overview
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
- Other This is a an observational prospective cohort study of a previous interventional trial (NCT04540575)
This is a an observational prospective cohort study
Primary outcome measures
- Cognition [Time frame: At 5-6 years of age]
- Societal costs [Time frame: Through 6 years of age]
Secondary outcome measures (8)
- Behavior [Time frame: Through 6 years of age]
- Executive functioning [Time frame: Through 6 years of age]
- Growth [Time frame: Through 6 years of age]
- Health-related quality of life [Time frame: Through 6 years of age]
- Adiposity [Time frame: Through 6 years of age]
- Blood pressure [Time frame: Through 6 years of age]
- Respiratory Health [Time frame: Through 6 years of age]
- Motor function [Time frame: Through 6 years of age]
Eligibility criteria
Inclusion criteria
Child was enrolled in ReDiMOM Child is alive
Exclusion criteria
Child is not alive
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
Identifiers
NCT: NCT07702357 · 24091703 · R01HD119178