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| ID | Type | Description | Link |
|---|---|---|---|
| KPRI Award | Other Identifier | UAB Department of Pediatrics |
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This is a masked randomized clinical trial in which extremely preterm infants fed human milk will be randomly assigned to receive either the highest (intervention group) or lowest (control group) vitamin D dose recommended during the first 14 days after birth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D group | Experimental |
| |
| Control group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D supplementation | Dietary Supplement | Study participants assigned to the intervention group will receive 800 IU/ day of vitamin D plus 200-300 IU/day of vitamin D from parenteral and enteral sources during the first 2 weeks after birth. |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of respiratory morbidity | A scoring system that defines severity of respiratory morbidity based on the amount of ventilatory support and the need for supplemental oxygen | 0 - 120 days |
| Non-invasive oscillometry (NiOS) measurements of pulmonary mechanics | Using the tremoflo N-100 Neo Oscillometry device, we will determine the area under the reactance curve (AX) | 40 - 120 days |
| Measure | Description | Time Frame |
|---|---|---|
| Bronchopulmonary dysplasia | Number of participants receiving ventilatory support or supplemental oxygen at 36 weeks of postmenstrual age (PMA) or discharge | 36 weeks PMA or discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40714046 | Derived | Salas AA, Argent T, Jeffcoat S, Tucker M, Ashraf AP, Travers CP. Early Vitamin D Supplementation in Infants Born Extremely Preterm and Fed Human Milk: A Randomized Controlled Trial. J Pediatr. 2025 Dec;287:114754. doi: 10.1016/j.jpeds.2025.114754. Epub 2025 Jul 24. |
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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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| No additional vitamin D supplementation | Other | Study participants assigned to the control group will receive 200-300 IU/ day of vitamin D from parenteral and enteral sources during the first 2 weeks after birth. |
|
| D000091642 | Urogenital Diseases |