Status:
COMPLETED
Ibuprofen and Renal Function in Premature Infants
Lead Sponsor:
Maternite Regionale Universitaire
Collaborating Sponsors:
Central Hospital, Nancy, France
Ministere de la Sante et de la Protection Sociale, France
Conditions:
Premature Infants
Patent Ductus Arteriosus
Eligibility:
All Genders
Up to 28 years
Phase:
PHASE4
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 arteriosu...
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 indica...
Eligibility Criteria
Inclusion
- Gestational Age = 27 to 31 weeks
- Postnatal age \< 48 hours
- Parental Consent Obtained
Exclusion
- Renal malformation
- Urinary tract infection
- Renal Failure
- Pulmonary Hypertension at echocardiography
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00217191
Start Date
September 1 2004
End Date
September 1 2006
Last Update
September 19 2006
Active Locations (3)
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1
CHU
Dijon, France, 21079
2
AP-HM (Néonatologie)
Marseille, France, 13000
3
Maternite Regionale Universitaire
Nancy, France, 54042