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| ID | Type | Description | Link |
|---|---|---|---|
| 911 | Other Identifier | Urochester |
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This is a feasibility study where Infants will be randomized to either chest shielding with aluminum foil or chest shielding without aluminum foil while undergoing phototherapy for premature infants. The primary outcome is patent ductus arteriosus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CALF | Experimental | Chest shield with aluminum foil |
|
| SHIELD | Sham Comparator | Chest shield without aluminum foil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chest shield with aluminum foil (CALF) | Device |
| ||
| SHIELD |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of symptomatic Patent ductus arteriosus | During first 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Nitric oxide level | During first 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Chronic lung disease | at 36 weeks post-menstrual age | |
| Incidence of Retinopathy of Prematurity | up to 44 weeks post-menstrual age | |
| Peak level of total serum bilirubin |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Javed Mannan, MD, MPH | University of Rochester | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38909157 | Derived | Mannan J, Amin SB. Effect of chest shielding during phototherapy for hyperbilirubinemia on symptomatic patent ductus arteriosus - a double-blind randomized placebo-controlled trial. Pediatr Res. 2024 Dec;96(7):1771-1776. doi: 10.1038/s41390-024-03310-4. Epub 2024 Jun 22. |
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| ID | Term |
|---|---|
| D007565 | Jaundice |
| ID | Term |
|---|---|
| D006932 | Hyperbilirubinemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
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|
| First 2 weeks |
| Duration of Phototherapy | First 2 weeks |
| Incidence of intraventricular hemorrhage | First 2 weeks |
| Incidence of surgical ligation for patent ductus arteriosus | First 4 weeks |
| D012816 | Signs and Symptoms |