Patent Ductus Arteriosus in Premature Infants
Conditions
Keywords
PDA, Jaundice, Phototherapy
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.
Interventions
DEVICEChest shield with aluminum foil (CALF)
DEVICESHIELD
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
23 Weeks to 33 Weeks
Healthy volunteers
No
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of symptomatic Patent ductus arteriosus | During first 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Urinary Nitric oxide level | During first 2 weeks |
Other
| Measure | Time frame |
|---|---|
| Incidence of surgical ligation for patent ductus arteriosus | First 4 weeks |
| Duration of Phototherapy | First 2 weeks |
| Incidence of Retinopathy of Prematurity | up to 44 weeks post-menstrual age |
| Peak level of total serum bilirubin | First 2 weeks |
| Incidence of Chronic lung disease | at 36 weeks post-menstrual age |
| Incidence of intraventricular hemorrhage | First 2 weeks |
Countries
United States
Outcome results
None listed