Ibuprofen and Renal Function in Premature Infants

This study has been completed.

Sponsor:

Collaborators:

Central Hospital, Nancy, France

Ministere de la Sante et de la Protection Sociale, France

Information provided by:

Maternite Regionale Universitaire

ClinicalTrials.gov Identifier:

NCT00217191

First received: September 14, 2005

Last updated: September 18, 2006

Last verified: September 2006

History of Changes

Purpose

Purpose of the 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.

Condition	Intervention	Phase
Premature Infants Patent Ductus Arteriosus	Drug: Ibuprofen	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Ibuprofen and Renal Function in Premature Infants

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies

Drug Information available for: Ibuprofen Ibuprofen sodium Ibuprofen lysinate

U.S. FDA Resources

Further study details as provided by Maternite Regionale Universitaire:

Primary Outcome Measures:

Creatinine Clearance on day seven postnatally

Secondary Outcome Measures:

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

Estimated Enrollment:	120
Study Start Date:	September 2004
Estimated Study Completion Date:	September 2006

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:

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.

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

Ages Eligible for Study:	up to 28 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00217191

Locations

France
CHU
Dijon, France, 21079
AP-HM (Néonatologie)
Marseille, France, 13000
Maternite Regionale Universitaire
Nancy, France, 54042

Sponsors and Collaborators

Maternite Regionale Universitaire

Central Hospital, Nancy, France

Ministere de la Sante et de la Protection Sociale, France

Investigators

Study Director:

Jean-Michel HASCOET, MD

University of Nancy, France

More Information

Additional Information:

Home page of the hospital This link exits the ClinicalTrials.gov site

Publications:

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Desandes R, Jellimann JM, Rouabah M, Haddad F, Desandes E, Boubred F, Semama DS, Vieux R, Hascoët JM. Echocardiography as a guide for patent ductus arteriosus ibuprofen treatment and efficacy prediction. Pediatr Crit Care Med. 2012 May;13(3):324-7.

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. Epub 2010 Apr 5.

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. Epub 2009 Nov 10.

ClinicalTrials.gov Identifier:	NCT00217191 History of Changes
Other Study ID Numbers:	MRAP040833, PHRC2004:17-06
Study First Received:	September 14, 2005
Last Updated:	September 18, 2006
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Maternite Regionale Universitaire:

Premature Infants
Patent ductus arteriosus
Renal function
Ibuprofen

Additional relevant MeSH terms:

Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013

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