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

Condition(s) targeted: Patent Ductus Arteriosus

Intervention: oral ibuprofen (Drug); intravenous ibuprofen (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hopital La Rabta

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.

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

Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Dose Comparison, Crossover Assignment, Efficacy Study

Primary outcome: rate of ductal closure

Secondary outcome: rate of side effects

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.

Minimum age: N/A. Maximum age: 96 Hours. Gender(s): Both.

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.

Maternity and Neonatal Center, tunis 1007, Tunisia

Starting date: January 2007
Ending date: December 2007
Last updated: March 24, 2008