A Phase 4 interventional study of oral ibuprofen and intravenous ibuprofen in Patent Ductus Arteriosus, sponsored by Hopital La Rabta. Completed at 1 site in Tunisia. Open to participants aged 48 Hours to 96 Hours. Per ClinicalTrials.gov, last updated 2008-03-25.
Sponsored by Hopital La Rabta · Phase 4, Interventional, and Treatment
it is a prospective randomized simple-blinded pilot trial with the principal aim to compare efficacy and tolerance between oral ibuprofen and intravenous ibuprofen in early curative closure of PDA in very low birth weight infants. The likelihood of ductal closure with only one or two doses of treatment is a secondary objective.
We calculated that a study group of 62 patients would be necessary for the study to be able to detect a difference of at least 25 percentage points in the closure rate between the oral ibuprofen and intravenous ibuprofen groups, assuming a closure rate of 65 percent with intravenous ibuprofen, with a p value of 0, 05 and a power of 80 percent.Patients (gestational age, 25 to 32 weeks) with echocardiographically confirmed patent ductus arteriosus and respiratory distress will randomly be assigned to receive one (10 mg / kg), two (10 mg / kg followed 24 hours after by 5 mg /kg) or three (10 mg / kg followed at 24-hour intervals by two doses of 5 mg /kg each) doses of either intravenous ibuprofen (group I, n = 32) or oral ibuprofen (group O, n = 32), starting on the third day of life. The rate of ductal closure, side effects, complications, and the patients' clinical course will be recorded.
144 studies on the registry are indexed under Ductus Arteriosus, Patent; 17 are open to participants now.
This study's enrollment of 62 is below the median of 80 across 81 interventional studies indexed under Ductus Arteriosus, Patent.
Browse Ductus Arteriosus, Patent studies →Hopital La Rabta is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Drug: intravenous ibuprofen
Drug: oral ibuprofen
one (10 mg / kg), two (10 mg / kg followed 24 hours after by 5 mg /kg) or three (10 mg / kg followed at 24-hour intervals by two doses of 5 mg /kg each) doses of oral ibuprofen starting on the third day of life.the number of doses is depending on echocardiographic findings concerning ductal closure.
one (10 mg / kg), two (10 mg / kg followed 24 hours after by 5 mg /kg) or three (10 mg / kg followed at 24-hour intervals by two doses of 5 mg /kg each) doses of oral ibuprofen starting on the third day of life.the number of doses is depending on echocardiographic findings concerning ductal closure.
rate of ductal closure
rate of side effects
This study is completed, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.
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Hopital La Rabta