Management of Patent Ductus in Premature Infants

December 12, 2013 updated by: National Heart, Lung, and Blood Institute (NHLBI)
To evaluate the effects (up to one year of age) of indomethacin on the clinical course of patent ductus arteriosus (PDA) in premature infants (24 hours old or less) and to assess the relative merits of indomethacin and surgery in infants with persistent respiratory distress who were not treated early with indomethacin. Two concurrent trials were performed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND:

The incidence of patent ductus arteriosus is higher in premature infants than in full-term infants and is highest in premature infants who have respiratory distress syndrome. It is generally agreed that intervention in an asymptomatic infant with a small left-to-right shunt is unnecessary, since the patent ductus almost invariably closes spontaneously and thus does not require surgery. A few infants will demonstrate signs of a large shunt during the course of respiratory distress syndrome. Many of these infants will improve with medical management of congestive heart failure, but others require surgical closure. A third group of babies with respiratory distress have severe progressive pulmonary disease requiring ventilatory support. There was disagreement as to whether elimination of the patent ductus in these infants resulted in decreased mortality. A variety of therapeutic approaches was being used, and there was no convincing evidence of the superiority of one treatment over another.

DESIGN NARRATIVE:

Trial A was a randomized, double-blind trial in which indomethacin plus usual medical therapy was compared with a placebo plus medical therapy. Where this regimen was unsuccessful, the code was broken, and infants who received indomethacin were treated surgically. Infants who had received placebo in Trial A were entered, if there were no contraindications to indomethacin, into Trial B. In Trial B, infants were randomized to surgery or indomethacin therapy. Those in whom indomethacin treatment was unsuccessful were treated surgically. The Recruitment and Intervention Phase began in April 1979. All patients were enrolled by March 31, 1981, and followed for one year after enrollment.

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Boy and girl premature infants with patent ductus arteriosus. Birth weight of 1,750 grams or less. Admitted to participating institution within first 24 hours of life.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Alexander Nadas, Children's Hospital & Medical Center

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1978

Study Completion (Actual)

March 1, 1982

Study Registration Dates

First Submitted

October 27, 1999

First Submitted That Met QC Criteria

October 27, 1999

First Posted (Estimate)

October 28, 1999

Study Record Updates

Last Update Posted (Estimate)

December 13, 2013

Last Update Submitted That Met QC Criteria

December 12, 2013

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13
  • R01HL023121 (Other Grant/Funding Number: US NIH Grant Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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