Brief Title
Ibuprofen and Renal Function in Premature Infants
Official Title
Ibuprofen and Renal Function in Premature Infants
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 Phase
Phase 4
Study Type
Interventional
Primary Outcome
Creatinine Clearance on day seven postnatally
Secondary Outcome
Rate of ductus closure after treatment
Condition
Premature Infants
Intervention
Ibuprofen
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
120
Start Date
September 2004
Completion Date
September 2006
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
Gender
All
Ages
N/A - 28 Days
Accepts Healthy Volunteers
No
Contacts
Jean-Michel HASCOET, MD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT00217191
Organization ID
MRAP040833
Secondary IDs
PHRC2004:17-06
Study Sponsor
Maternite Regionale Universitaire
Collaborators
Central Hospital, Nancy, France
Study Sponsor
Jean-Michel HASCOET, MD, Study Director, University of Nancy, France
Verification Date
September 2006