NCT00217191

Ibuprofen and Renal Function in Premature Infants

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (planned)
• Sponsor: Maternite Regionale Universitaire · Academic / Other
• Sex: All
• Age: 0 Years – 28 Days
• Healthy volunteers: Not accepted

Summary

Purpose of the study: 1. To evaluate renal function maturation within the first month of life in very premature infants. 2. To determine whether a treatment with Ibuprofen for patent ductus arteriosus would alter renal function maturation at short term and up to 28 days of life.

Detailed description

Ibuprofen has improved the prognosis of infants with Patent Ductus Arteriosus. Several studies showed that Ibuprofen has significantly less side effects than Indomethacin that was used for this indication. However, experimental studies and few clinical observations suggested that side effects on renal function could occur in very premature infants. Purpose of the study: 1. To evaluate renal function maturation within the first month of life in very premature infants. 2. To determine whether a treatment with Ibuprofen for patent ductus arteriosus would alter renal function maturation at short term and up to 28 days of life. Population: At least 120 infants 27 to 31 weeks gestation will be studied. That number will allow to demonstrate a 30% difference in creatinine clearance on day 7 postnatally. Careful recording of mother and child history, and associated therapies prone to alter renal function should allow to improve the use of this treatment.

Conditions

• Premature Infants
• Patent Ductus Arteriosus

Interventions

Type	Name	Description
DRUG	Ibuprofen

Timeline

• Start date: 2004-09-01
• Completion: 2006-09-01
• First posted: 2005-09-22
• Last updated: 2006-09-19

Locations

3 sites across 1 country: France