Comparative Study of Efficacy and Safety of Oral Ibuprofen and Intravenous Ibuprofen in Closure of Patent Ductus Arteriosus in Very Low Birth Weight Infants

PHASE4CompletedINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

January 31, 2007

Primary Completion Date

March 31, 2007

Study Completion Date

December 31, 2007

Conditions
Patent Ductus Arteriosus
Interventions
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.

DRUG

intravenous 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.

Trial Locations (1)

1007

Maternity and Neonatal Center, Tunis

All Listed Sponsors
collaborator

maternity and neonatal center

UNKNOWN

lead

Hopital La Rabta

OTHER

NCT00642330 - Comparative Study of Efficacy and Safety of Oral Ibuprofen and Intravenous Ibuprofen in Closure of Patent Ductus Arteriosus in Very Low Birth Weight Infants | Biotech Hunter | Biotech Hunter