Ibuprofen and Renal Function in Premature Infants

Phase 4

Completed

• Conditions: Premature Infants; Patent Ductus Arteriosus

• Registration Number: NCT00217191
• Lead Sponsor: Maternite Regionale Universitaire

Brief 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.

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-19
• Study First Posted: 2005-09-22
• Status Verified: 2006-09
• Study Completion: 2006-09
• Last Update Submitted: 2006-09-18
• Last Update Posted: 2006-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Gestational Age = 27 to 31 weeks
• Postnatal age < 48 hours
• Parental Consent Obtained

Exclusion Criteria

• Renal malformation
• Urinary tract infection
• Renal Failure
• Pulmonary Hypertension at echocardiography

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Creatinine Clearance on day seven postnatally

Secondary Outcome Measures

Name	Time	Method
Rate of ductus closure after treatment
Mortality
Rate of necrotizing enterocolitis
Rate and severity of Intraventricular Hemorrhage
Renal function maturation over 28 days

Trial Locations

Locations (3)

CHU; 🇫🇷 Dijon, France

AP-HM (Néonatologie); 🇫🇷 Marseille, France

Maternite Regionale Universitaire; 🇫🇷 Nancy, France