Treatment of a PDA With Acetaminophen in Preterm Neonates: Exploring Various Indications
- Registration Number
- NCT03289390
- Lead Sponsor
- Albany Medical College
- Brief Summary
This study will evaluate the use of acetaminophen in preterm infants when a patent ductus arteriosus (PDA) is of concern. We will perform two simultaneous prospective observational studies over a 3 year period. The first will be of infants with clinically significant PDAs beyond 14 days of life who are medically treated with acetaminophen as a means to avoid surgical ligation, and the second will be of infants who received acetaminophen for a PDA closure during the first 2 weeks of life as a result of ibuprofen, the current standard of care in our NICU, contraindication due to medical status.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
- Infants born at 23 0/7 to 29 6/7 weeks gestation, with PDA determined by medical team to need treatment and infant is beyond 14 days of life.
- Congenital heart disease Pneumonia Pulmonary hypertension Pulmonary hemorrhage ALT and AST ≥ 2X the upper limit of normal (=AST> 150 U/L, ALT>90 U/L) Sepsis/meningitis Abnormal chromosomes Hydrops Major congenital malformations
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Acetaminophen to close PDA Acetaminophen Infants with PDA treated with acetaminophen beyond 14 days of life or in whom acetaminophen is used due to contraindication to ibuprofen
- Primary Outcome Measures
Name Time Method Change in PDA size 3 days Size of PDA will be measured by echocardiography to determine if the size has changed after treatment is complete.
Rate of PDA closure 3 days PDA will be evaluated by echocardiography to determined whether it has closed after treatment is complete.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Albany Medical Center
🇺🇸Albany, New York, United States