search
Back to results

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

Primary Purpose

Patent Ductus Arteriosus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
indomethacin (two different dosing regimens)
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Patent Ductus Arteriosus focused on measuring prematurity, chronic lung disease, necrotizing enterocolitis, indomethacin, ductus arteriosus

Eligibility Criteria

undefined - 48 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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).

Sites / Locations

  • University of California San Francisco
  • University of Chicago
  • Brown University

Outcomes

Primary Outcome Measures

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 Outcome Measures

Altered renal function during treatment
Incidence of Necrotizing enterocolitis
Incidence of chronic lung disease

Full Information

First Posted
September 10, 2005
Last Updated
June 2, 2008
Sponsor
University of California, San Francisco
search

1. Study Identification

Unique Protocol Identification Number
NCT00187447
Brief Title
Comparison of 2 Different Indomethacin Dosing Protocols to Treat Infants Delivered at <28 Weeks Gestation With a Persistent Patent Ductus Arteriosus
Official Title
Comparison of 2 Different Indomethacin Dosing Protocols to Treat Infants Delivered at <28 Weeks Gestation With a Persistent Patent Ductus Arteriosus
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, San Francisco

4. Oversight

5. Study Description

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.
Detailed Description
This study is a Phase II randomized, masked, controlled trial that compares the current standard dose of indomethacin to a higher dose for the closure of PDA in premature infants less than 28 weeks of gestation. Neonates (<28 weeks gestation) who are started on indomethacin treatment (with an initial 3-dose course: 0.2, 0.1, and 0.1 mg/kg of indomethacin) within the first 96 hr after birth will be eligible for this trial if they continue to have Doppler evidence of ductus patency before the third dose of indomethacin. This group of infants have greater than 65% chance of developing symptomatic PDA and surgical ligation even after our standard extended course of indomethacin. Those infants who do not fit the exclusion criteria will be randomized to either a Standard Dose group or to a Higher Dose group after obtaining consent. The infants randomized to the standard group will receive a 4th, 5th, and 6th dose of indomethacin (0.1 mg/kg) at 24 hr intervals (starting at 24 hr after the 3rd dose). The Higher Dose group infants delivered between 26-27 weeks gestation will receive a 4th, 5th, 6th, 7th, 8th and 9th dose of indomethacin (0.1mg/kg) at 12 hr intervals (starting 12 hr after the 3rd dose). The Higher Dose group infants between 24-25 weeks gestation will receive a 4th, 5th, 6th, 7th, 8th and 9th dose of indomethacin (0.25mg/kg) at 12 hour intervals (starting 12 hr after the 3rd dose). To keep the study blinded, the standard group will receive 3 extra doses of saline to match the 3 additional doses given to the higher dose group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patent Ductus Arteriosus
Keywords
prematurity, chronic lung disease, necrotizing enterocolitis, indomethacin, ductus arteriosus

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
indomethacin (two different dosing regimens)
Primary Outcome Measure Information:
Title
The incidence of ductus closure, as determined by echocardiography, following the last dose of study drug
Title
The incidence of the appearance of a symptomatic PDA following the last dose of study drug
Title
The incidence of ductus ligation.
Secondary Outcome Measure Information:
Title
Altered renal function during treatment
Title
Incidence of Necrotizing enterocolitis
Title
Incidence of chronic lung disease

10. Eligibility

Sex
All
Maximum Age & Unit of Time
48 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Clyman, M.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
Davis
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs