NCT03289390

Treatment of a PDA With Acetaminophen in Preterm Neonates: Exploring Various Indications

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 11 (actual)
• Sponsor: Albany Medical College · Academic / Other
• Sex: All
• Age: 23 Weeks – 30 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Patent Ductus Arteriosus

Interventions

Type	Name	Description
DRUG	Acetaminophen	Acetaminophen given at discretion of medical team for PDA treatment. Research team to evaluate pre and post laboratory values and echocardiograms.

Timeline

• Start date: 2017-08-01
• Primary completion: 2019-06-30
• Completion: 2019-06-30
• First posted: 2017-09-21
• Last updated: 2020-01-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study