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Management of Patent Ductus in Premature Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000494
First Posted: October 28, 1999
Last Update Posted: March 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
October 27, 1999
October 28, 1999
March 17, 2014
September 1978
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Complete list of historical versions of study NCT00000494 on ClinicalTrials.gov Archive Site
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Management of Patent Ductus in Premature Infants
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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.

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.

Interventional
Phase 3
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
  • Cardiovascular Diseases
  • Defect, Congenital Heart
  • Ductus Arteriosus, Patent
  • Heart Diseases
  • Drug: indomethacin
  • Procedure: surgery, cardiovascular
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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March 1982
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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.
Sexes Eligible for Study: All
up to 1 Year   (Child)
No
Contact information is only displayed when the study is recruiting subjects
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NCT00000494
13
R01HL023121 ( Other Grant/Funding Number: US NIH Grant Number )
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National Heart, Lung, and Blood Institute (NHLBI)
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Investigator: Alexander Nadas Children's Hospital & Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP