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| ID | Type | Description | Link |
|---|---|---|---|
| A536757 | Other Identifier | UW Madison | |
| SMPH/PEDIATRICS/PEDIATRICS | Other Identifier | UW Madison | |
| Protocol Version 9/11/2024 | Other Identifier | UW Madison | |
| 2023-023 | Other Identifier | Meriter |
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| Name | Class |
|---|---|
| Meriter Hospital, Inc. | UNKNOWN |
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The goal of this clinical trial is to learn more about how the food and nutrition babies receive while in the Neonatal Intensive Care Unit (NICU) influences their ability to gain weight and fat-free mass, and their future growth and development.
Participants will:
Participants can expect to be in the study for 36 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEAPOD device | Premature babies will be evaluated using the PEAPOD Infant Body Composition measuring device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEAPOD Infant Body Composition measuring device | Device | PEAPOD is a device to that collects body composition measurements. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the correlation between nutritional intake over the first two weeks of life and the percent increase in fat-free mass measured by the PEAPOD | The least absolute shrinkage and selection operator technique will be utilized to determine whether fat intake predicts a percent increase in fat-free mass | Birth to 2 weeks |
| To evaluate the correlation between higher nutritional intake in the first 2 weeks of life and the General Movement Assessment (GMA) and/or the Bayley Scales of Infant and Toddler Developmental Scores (Bayley) | The least absolute shrinkage and selection operator technique will be utilized to determine whether higher nutritional intake predicts Bayley cognitive scores | Birth to 36 months |
| To evaluate the correlation between the percent increase in fat-free mass and the GMA and/or Bayley scores. | The least absolute shrinkage and selection operator technique will be utilized to determine whether the percent increase in fat-free mass predicts GMA scores and Bayley scores. | Birth to 36 months |
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Neonate Inclusion Criteria:
Neonate Exclusion Criteria:
Known genetic condition that impacts neurodevelopmental outcomes or brain structure development
Multiple major congenital anomalies
Per the investigator's opinion, the subject will likely require transfer to American Family Children's Hospital (AFCH) before 36 weeks PMA
Birthing Parent Inclusion Criteria:
Birthing Parent Exclusion Criteria:
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120 neonates born inpatient at Meriter Hospital, Inc. ≤ 32 weeks 6 days (32w6d) GA (possible gestational age range from 22w0d-32w6d)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Whitley Hulse, MD | Contact | 608-620-4924 | whulse@wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Whitley Hulse, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meriter Hospital, Inc. | Recruiting | Madison | Wisconsin | 53715 | United States |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D005317 | Fetal Growth Retardation |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| D000091642 | Urogenital Diseases |
| D005315 | Fetal Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |