Clinical trial NCT00217191: Ibuprofen and Renal Function in Premature Infants
Official title: Ibuprofen and Renal Function in Premature Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Premature Infants
Patent Ductus Arteriosus
Keywords: Premature Infants
Patent ductus arteriosus
Renal function
Ibuprofen
Lead sponsor: Maternite Regionale Universitaire
Sponsor class: OTHER
Collaborators: name: Central Hospital, Nancy, France
name: Ministere de la Sante et de la Protection Sociale, France
First posted: 2005-09-22
Enrollment: 120
Sex: ALL
Minimum age (years): 0
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Creatinine Clearance on day seven postnatally
Secondary outcomes:
measure: Rate of ductus closure after treatment
measure: Mortality
measure: Rate of necrotizing enterocolitis
measure: Rate and severity of Intraventricular Hemorrhage
measure: Renal function maturation over 28 days
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU
city: Marseille
country: France
facility: AP-HM (Néonatologie)
city: Nancy
country: France
facility: Maternite Regionale Universitaire
Study officials:
affiliation: University of Nancy, France
name: Jean-Michel HASCOET, MD
role: STUDY_DIRECTOR
References:
citation: Gournay V, Roze JC, Kuster A, Daoud P, Cambonie G, Hascoet JM, Chamboux C, Blanc T, Fichtner C, Savagner C, Gouyon JB, Flurin V, Thiriez G. Prophylactic ibuprofen versus placebo in very premature infants: a randomised, double-blind, placebo-controlled trial. Lancet. 2004 Nov 27-Dec 3;364(9449):1939-44. doi: 10.1016/S0140-6736(04)17476-X.
citation: Desandes R, Jellimann JM, Rouabah M, Haddad F, Desandes E, Boubred F, Semama DS, Vieux R, Hascoet JM. Echocardiography as a guide for patent ductus arteriosus ibuprofen treatment and efficacy prediction. Pediatr Crit Care Med. 2012 May;13(3):324-7. doi: 10.1097/PCC.0b013e31822882b5.
citation: Vieux R, Hascoet JM, Merdariu D, Fresson J, Guillemin F. Glomerular filtration rate reference values in very preterm infants. Pediatrics. 2010 May;125(5):e1186-92. doi: 10.1542/peds.2009-1426. Epub 2010 Apr 5.
citation: Vieux R, Desandes R, Boubred F, Semama D, Guillemin F, Buchweiller MC, Fresson J, Hascoet JM. Ibuprofen in very preterm infants impairs renal function for the first month of life. Pediatr Nephrol. 2010 Feb;25(2):267-74. doi: 10.1007/s00467-009-1349-9. Epub 2009 Nov 10.