Skip to main content
Clinical Trials/NCT00217191
NCT00217191
Completed
Phase 4

Ibuprofen and Renal Function in Premature Infants

Maternite Regionale Universitaire3 sites in 1 country120 target enrollmentSeptember 2004

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Premature Infants
Sponsor
Maternite Regionale Universitaire
Enrollment
120
Locations
3
Primary Endpoint
Creatinine Clearance on day seven postnatally
Status
Completed
Last Updated
19 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2004
End Date
September 2006
Last Updated
19 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Sponsor
Maternite Regionale Universitaire

Eligibility Criteria

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

Outcomes

Primary Outcomes

Creatinine Clearance on day seven postnatally

Secondary Outcomes

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

Study Sites (3)

Loading locations...

Similar Trials