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

Patent Ductus Arteriosus Clinical Trial

Official title:

Randomized Pilot Study Comparing Oral Ibuprofen With Intravenous Ibuprofen in Very Low Birth Weight Infants With Patent Ductus Arteriosus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00642330
• Other study ID #: IBU-001
• Secondary ID: TIS-1447FMND-458
• Status: Completed
• Phase: Phase 4
• First received: March 17, 2008
• Last updated: March 24, 2008
• Start date: January 2007
• Est. completion date: December 2007

Study information

• Verified date: March 2008
• Source: Hopital La Rabta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tunisia: Ministry of Public Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 96 Hours

Eligibility

Inclusion Criteria:

• a gestational age < 32 weeks

• a birth weight < 1500g

• a postnatal age between 48 and 96 hours, a respiratory distress requiring more than 25 % of oxygen supplementation

• an echocardiographic evidence of left to right significant shunting PDA

Exclusion Criteria:

• a right-to-left shunting

• major congenital anomalies

• IVH grade 3-4

• a tendency to bleed (defined by the presence of blood in the endotracheal aspirate, gastric aspirate, stools or urines and / or oozing from puncture sites)

• a serum creatinine level >140µmol/l, a serum urea nitrogen > 14 µmol/l and a platelet count < 60000/mm3.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Birth Weight
• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus

Intervention

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.
• 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.

Locations

Country	Name	City	State
Tunisia	Maternity and Neonatal Center	Tunis

Sponsors (2)

Lead Sponsor	Collaborator
Hopital La Rabta	maternity and neonatal center

Country where clinical trial is conducted

Tunisia, 

References & Publications (1)

Cherif A, Jabnoun S, Khrouf N. Oral ibuprofen in early curative closure of patent ductus arteriosus in very premature infants. Am J Perinatol. 2007 Jun;24(6):339-45. Epub 2007 Jun 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of ductal closure			Yes
Secondary	rate of side effects			Yes