PretermNCT07702357
Preschool Outcomes of a Previous RCT - ReDiMOM (NCT04540575)
An observational study of Preterm, run by Rush University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Preterm
- What is being tested?
- This is a an observational prospective cohort study of a previous interventional trial (NCT04540575)
- How many people
- 256 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2026to 31 May 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: All surviving children and their mothers who were enrolled in ReDiMOM RCT will be offered enrollment into this prospective observational study.
Who may be able to join
- Child was enrolled in ReDiMOM Child is alive
Who cannot join
- Child is not alive
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: 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.
- Conditions
- Preterm
- Being tested
- This is a an observational prospective cohort study of a previous interventional trial (NCT04540575)
- Keywords
- milk, cognition, health, executive function, quality of life, economic outcome, motor
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is a an observational prospective cohort study of a previous interventional trial (NCT04540575)Other
This is a an observational prospective cohort study
| Study group | Role | What they receive |
|---|---|---|
| ReDiMOM | Participants that were previously subjects in the ReDiMOM RCT (NCT04540575) Receives: Other: This is a an observational prospective cohort study of a previous interventional trial (NCT04540575) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition
Cognitive outcome tested by the Wechsler Preschool and Primary Scale of Intelligence
Measured: 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).
Measured: Through 6 years of age
Secondary outcomes (8)
Behavior
Behavior will be evaluated with the Behavioral Assessment System for Children-Third Edition (BASC-3)
Measured: Through 6 years of age
Executive functioning
Executive functioning will be evaluated with the Behavioral Assessment System for Children-Third Edition (BASC-3)
Measured: Through 6 years of age
Growth
Anthropometric measurements taken annually
Measured: Through 6 years of age
Health-related quality of life
Health-related quality of life will be measured via the EQ-5D-Y
Measured: Through 6 years of age
Adiposity
Adiposity will be measured annually using Bioelectrical Impedance Analysis (BIA)
Measured: Through 6 years of age
Blood pressure
Measured annually
Measured: Through 6 years of age
Respiratory Health
History of recurrent wheeze or asthma will be collected via questionnaires
Measured: Through 6 years of age
Motor function
Motor function will be assessed with the Movement Assessment Battery for Children, Third Edition (MABC-3)
Measured: Through 6 years of age
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 start6 Mar 2026
- Primary completion31 May 2030 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- 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
- 256 participants (estimated)
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
- NCT07702357
- Sponsor's protocol ID
- 24091703
- Other IDs
- R01HD119178
- 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: Deidentified data that are aggregated to the analytic unit of analysis (e.g., subject, year) will be made available via Open Science Framework.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07702357
- Acronym / sponsor ID
- 24091703
- Conditions
- Preterm
- Keywords
- milk, cognition, health, executive function, quality of life, economic outcome, motor
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 6 Mar 2026 (actual)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ReDiMOM | – | Other: This is a an observational prospective cohort study of a previous interventional trial (NCT04540575)Participants that were previously subjects in the ReDiMOM RCT (NCT04540575) |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All surviving children and their mothers who were enrolled in ReDiMOM RCT will be offered enrollment into this prospective observational study.
Key inclusion criteria (1 listed)
- Child was enrolled in ReDiMOM Child is alive
Key exclusion criteria (1 listed)
- Child is not alive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is a an observational prospective cohort study of a previous interventional trial (NCT04540575)This is a an observational prospective cohort study | Other | ReDiMOM |
Primary outcome
Cognition
Time frame: At 5-6 years of age
Cognitive outcome tested by the Wechsler Preschool and Primary Scale of Intelligence
Societal costs
Time frame: 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).
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: Yes. Deidentified data that are aggregated to the analytic unit of analysis (e.g., subject, year) will be made available via Open Science Framework.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aloka L Patel, MD principal investigator
Rush University
Tricia Johnson, PhD principal investigator
Rush University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognition (time frame: At 5-6 years of age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.