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

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Indomethacin

Criteria

Inclusion Criteria:

1. Newborn infants of less than 28 weeks gestational age who are treated with indomethacin during the first 48 hours after birth

2. Presence of patent ductus arteriosus (PDA) by Doppler echocardiography between the second and third dose of indomethacin.

3. Creatinine ≤1.8 mg/dl

4. Platelets ≥ 50,000

Exclusion Criteria:

1. Chromosomal disorders.

2. Major congenital anomalies.

3. Contraindications for indomethacin

1. Necrotizing enterocolitis, by clinical or radiological evidence

2. 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).