Comparison of 2 Different Indomethacin Dosing Protocols to Treat Infants Delivered at <28 Weeks Gestation With a Persistent Patent Ductus Arteriosus

Completed · Phase 2

Conditions studied: Patent Ductus Arteriosus

In brief

The purpose of this study is to examine if a higher dose of indomethacin will increase the rate of ductus arteriosus closure in extremely premature infants without increasing the side effects. The long term objective is to find the optimal dosing of indomethacin for permanent closure of the Ductus and prevent the morbidity related to PDA and the complications of surgical ligation.

Key facts

Study ID

NCT00187447

Run by

University of California, San Francisco

People needed

100

Starts

2003-08-01

Expected to finish

2006-07-01

Last updated by the study team

2008-06-04

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newborn infants of less than 28 weeks gestational age who are treated with indomethacin during the first 48 hours after birth
• Presence of patent ductus arteriosus (PDA) by Doppler echocardiography between the second and third dose of indomethacin.
• Creatinine ≤1.8 mg/dl
• Platelets ≥ 50,000

You may not qualify if…

• Chromosomal disorders.
• Major congenital anomalies.
• Contraindications for indomethacin
• Necrotizing enterocolitis, by clinical or radiological evidence
• Evidence of bleeding diathesis as evidenced by pulmonary hemorrhage, persistent oozing from puncture sites, grossly bloody stool (Note: Infants with an intracranial hemorrhage can be enrolled in this study).

Where it is running

• University of California San Francisco — Davis, California, United States
• University of Chicago — Chicago, Illinois, United States
• Brown University — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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