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Home > "M" Clinical Trials Conditions > Management of Patent Ductus in Premature Infants  Management of Patent Ductus in Premature Infants
Management of Patent Ductus in Premature Infants
For Condition: Cardiovascular Diseases,Defect, Congenital Heart,Ductus Arteriosus, Patent,Heart Diseases
Status: Completed
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind
Minimum Age/Maximum Age: /1 Year
Genders: Both
Protocol Entry 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.
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AlexanderNadas, , Children's Hospital Medical Center
Additional Information:
Study ID Numbers: 13;
Study Start Date: September 1978
Record last reviewed: October 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000494
Other Defect, Congenital Heart Studies:
1. Hematocrit Strategy in Infant Heart Surgery
2. Reproduction and Survival After Cardiac Defect Repair
3. Pediatric Heart Disease Clinical Research Network
4. Management of Patent Ductus in Premature Infants
5. Infant Heart Surgery: Central Nervous System Sequelae of Circulatory Arrest
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Management of Patent Ductus in Premature Infants
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