Management of Patent Ductus in Premature Infants

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00000494
First received: October 27, 1999
Last updated: December 12, 2013
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Cardiovascular Diseases
Defect, Congenital Heart
Ductus Arteriosus, Patent
Heart Diseases
Drug: indomethacin
Procedure: surgery, cardiovascular
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 1978
Study Completion Date: March 1982
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.

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00000494

Sponsors and Collaborators
Investigators
Investigator: Alexander Nadas Children's Hospital Medical Center
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00000494     History of Changes
Other Study ID Numbers: 13, R01HL023121
Study First Received: October 27, 1999
Last Updated: December 12, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Congenital Abnormalities
Cardiovascular Diseases
Ductus Arteriosus, Patent
Heart Defects, Congenital
Heart Diseases
Cardiovascular Abnormalities
Indomethacin
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Cardiovascular Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 26, 2014