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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hopital La Rabta
• Collaborator: maternity and neonatal center
• Treatments: Ibuprofen

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.