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

NCT03289390 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 11

Last updated 2020-01-13

No results posted yet for this study

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

DRUG

Acetaminophen

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

Sponsors & Collaborators

  • Albany Medical College

    lead OTHER

Eligibility

Min Age
23 Weeks
Max Age
30 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2019-06-30
Completion
2019-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03289390 on ClinicalTrials.gov