Management of Patent Ductus in Premature Infants

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ClinicalTrials.gov Identifier: NCT00000494

Recruitment Status : Completed

First Posted : October 28, 1999

Last Update Posted : December 13, 2013

Sponsor:

Information provided by:

National Heart, Lung, and Blood Institute (NHLBI)

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Cardiovascular Diseases Defect, Congenital Heart Ductus Arteriosus, Patent Heart Diseases	Drug: indomethacin Procedure: surgery, cardiovascular	Phase 3

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 Design


Study Type :	Interventional (Clinical Trial)
Allocation:	Randomized
Masking:	Double
Primary Purpose:	Treatment
Study Start Date :	September 1978
Actual Study Completion Date :	March 1982

Resource links provided by the National Library of Medicine

Drug Information available for: Indomethacin

Genetic and Rare Diseases Information Center resources: Patent Ductus Arteriosus

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	up to 1 Year (Child)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000494

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators


OverallOfficial:	Alexander Nadas	Children's Hospital & Medical Center

More Information

Publications:

Gersony WM, Peckham GJ, Ellison RC, Miettinen OS, Nadas AS. Effects of indomethacin in premature infants with patent ductus arteriosus: results of a national collaborative study. J Pediatr. 1983 Jun;102(6):895-906.

Ellison RC, Peckham GJ, Lang P, Talner NS, Lerer TJ, Lin L, Dooley KJ, Nadas AS. Evaluation of the preterm infant for patent ductus arteriosus. Pediatrics. 1983 Mar;71(3):364-72.


ClinicalTrials.gov Identifier:	NCT00000494 History of Changes
Other Study ID Numbers:	13 R01HL023121 ( Other Grant/Funding Number: US NIH Grant Number )
First Posted:	October 28, 1999 Key Record Dates
Last Update Posted:	December 13, 2013
Last Verified:	April 2012

Additional relevant MeSH terms:


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

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