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
  Purpose

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.

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:


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:

  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 September 18, 2014