Chest Shielding in Premature Infants During Phototherapy
Not Applicable
Completed
- Conditions
- Patent Ductus Arteriosus in Premature Infants
- Interventions
- Device: Chest shield with aluminum foil (CALF)Device: SHIELD
- Registration Number
- NCT02552927
- Lead Sponsor
- University of Rochester
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- less or equal to 29 weeks or 1000g at birth
- Admitted to the NICU (Neonatal intensive care unit) within 24 hours after birth
- English speaking parents
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Exclusion Criteria
- Congenital abnormalities
- Chromosomal disorders
- Cyanotic heart defects
- Nitric oxide
- Prophylactic phototherapy
- Unlikely to survive beyond 72 hours according to the attending neonatologist
- Do not require phototherapy
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CALF Chest shield with aluminum foil (CALF) Chest shield with aluminum foil SHIELD SHIELD Chest shield without aluminum foil
- Primary Outcome Measures
Name Time Method Incidence of symptomatic Patent ductus arteriosus During first 2 weeks
- Secondary Outcome Measures
Name Time Method Urinary Nitric oxide level During first 2 weeks
Trial Locations
- Locations (1)
University of Rochester
🇺🇸Rochester, New York, United States