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

NCT00187447 | Completed Phase 2

• 1 other identifier: RC1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Patent Ductus Arteriosus

Keywords

prematurity; chronic lung disease; necrotizing enterocolitis; indomethacin; ductus arteriosus

Outcome Measures

Primary Outcomes (3)

• The incidence of ductus closure, as determined by echocardiography, following the last dose of study drug

• The incidence of the appearance of a symptomatic PDA following the last dose of study drug

• The incidence of ductus ligation.

Secondary Outcomes (3)

• Altered renal function during treatment

• Incidence of Necrotizing enterocolitis

• Incidence of chronic lung disease

Interventions

indomethacin (two different dosing regimens) DRUG

Eligibility Criteria

• Age: Up to 48 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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).

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (3)

University of California San Francisco

Davis, California, 94143, United States

Location

University of Chicago

Chicago, Illinois, United States

Location

Brown University

Providence, Rhode Island, United States

Location

MeSH Terms

Conditions

Ductus Arteriosus, Patent; Premature Birth; Enterocolitis, Necrotizing

Interventions

Indomethacin

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ronald Clyman, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 10, 2005
• First Posted: September 16, 2005
• Study Start: August 1, 2003
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: June 4, 2008

Record last verified: 2005-09

Locations

US (3)