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Trial NCT00000494

Resource URI: http://static.linkedct.org/resource/trials/NCT00000494
linkedct:brief_title Management of Patent Ductus in Premature Infants
linkedct:condition <http://static.linkedct.org/resource/condition/2312>
linkedct:condition <http://static.linkedct.org/resource/condition/3619>
linkedct:condition <http://static.linkedct.org/resource/condition/4103>
linkedct:condition <http://static.linkedct.org/resource/condition/5702>
linkedct: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.
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 1 Year
linkedct:eligibility_minimum_age N/A
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000494
rdfs:label Trial NCT00000494
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000494
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 13
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/1367>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000494>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/43267>
linkedct:reference <http://static.linkedct.org/resource/reference/43287>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date September 1978
linkedct:study_design Treatment, Randomized, Double-Blind
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date October 2001