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

NCT ID: NCT00642330

Last Updated: 2008-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2007-12-31

Brief 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.

Detailed 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.

Conditions

Patent Ductus Arteriosus

Keywords

patent; ductus; arteriosus; ibuprofen; premature; infant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

I

Group Type: ACTIVE_COMPARATOR

intravenous ibuprofen

Intervention Type: DRUG

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.

O

Group Type: ACTIVE_COMPARATOR

oral ibuprofen

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 48 Hours
• Maximum Eligible Age: 96 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

maternity and neonatal center

UNKNOWN

Sponsor Role: collaborator

Hopital La Rabta

OTHER

Sponsor Role: lead

Responsible Party

Hopital La Rabta

Locations

Maternity and Neonatal Center

Tunis, , Tunisia

Countries

Tunisia

References

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. doi: 10.1055/s-2007-981853. Epub 2007 Jun 12.

Reference Type: RESULT

PMID: 17564958 (View on PubMed)

Cherif A, Khrouf N, Jabnoun S, Mokrani C, Amara MB, Guellouze N, Kacem S. Randomized pilot study comparing oral ibuprofen with intravenous ibuprofen in very low birth weight infants with patent ductus arteriosus. Pediatrics. 2008 Dec;122(6):e1256-61. doi: 10.1542/peds.2008-1780.

Reference Type: DERIVED

PMID: 19047225 (View on PubMed)

Other Identifiers

TIS-1447

Identifier Type: -

Identifier Source: secondary_id

FMND-4585

Identifier Type: -

Identifier Source: secondary_id

IBU-001

Identifier Type: -

Identifier Source: org_study_id