Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000494
Status:
COMPLETED
Last Update Posted:
2013-12-13
First Post:
1999-10-27
Brief Title:
Management of Patent Ductus in Premature Infants
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL023121 | OTHER_GRANT | US NIH Grant Number | None |