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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD119178 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ReDiMOM | Participants that were previously subjects in the ReDiMOM RCT (NCT04540575) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| This is a an observational prospective cohort study of a previous interventional trial (NCT04540575) | Other | This is a an observational prospective cohort study |
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| Measure | Description | Time Frame |
|---|---|---|
| Cognition | Cognitive outcome tested by the Wechsler Preschool and Primary Scale of Intelligence | 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). | Through 6 years of age |
| Measure | Description | Time Frame |
|---|---|---|
| Behavior | Behavior will be evaluated with the Behavioral Assessment System for Children-Third Edition (BASC-3) | Through 6 years of age |
| Executive functioning | Executive functioning will be evaluated with the Behavioral Assessment System for Children-Third Edition (BASC-3) |
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Inclusion Criteria:
Child was enrolled in ReDiMOM Child is alive
Exclusion Criteria:
Child is not alive
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All surviving children and their mothers who were enrolled in ReDiMOM RCT will be offered enrollment into this prospective observational study.
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| Name | Affiliation | Role |
|---|---|---|
| Aloka L Patel, MD | Rush University | Principal Investigator |
| Tricia Johnson, PhD | Rush University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University | Chicago | Illinois | 60612 | United States |
Deidentified data that are aggregated to the analytic unit of analysis (e.g., subject, year) will be made available via Open Science Framework.
Final submission and release of the study data will occur approximately 18 to 24 months following the end of data processing and creation of final data files or by the date of publication of the final study results, if publication occurs sooner. Study data deposited into Open Science Framework will be available in the repository for at least 5 years.
Study data and associated documentation will be made available to the research community free of charge through the Open Source Framework data repository (https://osf.io).
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Through 6 years of age |
| Growth | Anthropometric measurements taken annually | Through 6 years of age |
| Health-related quality of life | Health-related quality of life will be measured via the EQ-5D-Y | Through 6 years of age |
| Adiposity | Adiposity will be measured annually using Bioelectrical Impedance Analysis (BIA) | Through 6 years of age |
| Blood pressure | Measured annually | Through 6 years of age |
| Respiratory Health | History of recurrent wheeze or asthma will be collected via questionnaires | Through 6 years of age |
| Motor function | Motor function will be assessed with the Movement Assessment Battery for Children, Third Edition (MABC-3) | Through 6 years of age |
| D000091642 | Urogenital Diseases |