Ibuprofen and Renal Function in Premature Infants
DEC-NET Serial number FR592
Published online12/10/2006 11.12.00
Last updated20/07/2006 17.05.54
Other protocol ID numberN/A
Current trial statusOpen (actively recruiting new participants)
Major Disease
(ICD9 class)		PATENT DUCTUS ARTERIOSUS
Experimental drug
IBUPROFEN
GenderBoth
Age (range)27 to 31 weeks

Eligibility criteria
Inclusion criteria
-Gestational Age = 27 to 31 weeks -Postnatal age < 48 hours -Parental Consent Obtained

Trial design/methodology
Phase4
Kind of studyProphylaxis
DesignActive control
Purpose of study
-To evaluate renal function maturation within the first month of life in very premature infants. -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.
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
Principal investigator
NameDr.Jean-Michel HASCOET
Institution
Postal address
City
Country
Phone
Fax
E-mail


Promoter
Maternité régionale universitaire (University)
Hôpital Central de Nancy (Scientific organisation)

ISRCTN  EudraCT