PretermNCT07702318
Early Childhood (2-year) Outcomes Among Former VLBW From the ReDiMOM Trial
An observational study of Preterm, run by Rush University Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 3 years
- Conditions the study is for
- Preterm
- How many people
- 275 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2022to 31 May 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: Participants were cared for in the Rush NICU in Chicago, IL and participated in the ReDiMOM randomized controlled trial.
Who may be able to join
- Completion of the ReDiMOM RCT
- survival of infant to NICU discharge
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Conditions
- Preterm
- Keywords
- milk, very preterm, economic intervention
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ReDiMOM | Participants were enrolled in ReDiMOM RCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition
Cognitive index scores on Bayley Scales of Infant and Toddler Development-4th Edition at 20 months CA.
Measured: 2 years
Adiposity
Adiposity measured by BIA
Measured: 2 years
MOM duration
Duration of partial and/or exclusive MOM feedings through the first year of life using questionnaire.
Measured: 1 year
Total costs
Total costs at 20 months CA will be determined from the societal perspective and defined as the sum of ReDiMOM intervention, healthcare, EI and associated family costs from birth to 20 months CA. Detailed intervention costs for each infant are already collected for the original ReDiMOM RCT. Healthcare costs will be obtained from 5 sources: 1) ReDiMOM RCT prospective database, 2) self-report questionnaire to assess family healthcare costs, 3) Medicaid claims, 4) Illinois State Early Intervention Database, and 5) RUMC system-wide cost-account and billing systems
Measured: 2 years
Language
Language index scores on Bayley Scales of Infant and Toddler Development-4th Edition at 20 months CA.
Measured: 2 years
Motor
Motor index scores on Bayley Scales of Infant and Toddler Development-4th Edition at 20 months CA.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start23 Sep 2022
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PretermStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 275 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Aloka L Patel, MD, Principal investigator, Rush UniversityTricia Johnson, PhD, Principal investigator, Rush University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702318
- Sponsor's protocol ID
- 20102003
- Other IDs
- R01HD107348
- Status last verified
- Jul 2026
- First submitted
- 26 Jun 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: de-identified and aggregated participant level data that underlie the results reported in the publication
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.
PubMed 41748748