Treatment of a PDA With Acetaminophen in Preterm Neonates: Exploring Various Indications
Completed
Conditions studied: Patent Ductus Arteriosus
In brief
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.
Key facts
- Study ID
- NCT03289390
- Run by
- Albany Medical College
- People needed
- 11
- Starts
- 2017-08-01
- Expected to finish
- 2019-06-30
- Last updated by the study team
- 2020-01-13
Who can join
Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Albany Medical Center — Albany, New York, United States
Full record on ClinicalTrials.gov
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