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Ibuprofen and Renal Function in Premature Infants

Primary Purpose

Premature Infants, Patent Ductus Arteriosus

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Ibuprofen
Sponsored by
Maternite Regionale Universitaire
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Infants focused on measuring Premature Infants, Patent ductus arteriosus, Renal function, Ibuprofen

Eligibility Criteria

0 Years - 28 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU
  • AP-HM (Néonatologie)
  • Maternite Regionale Universitaire

Outcomes

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

Full Information

First Posted
September 14, 2005
Last Updated
September 18, 2006
Sponsor
Maternite Regionale Universitaire
Collaborators
Central Hospital, Nancy, France, Ministere de la Sante et de la Protection Sociale, France
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1. Study Identification

Unique Protocol Identification Number
NCT00217191
Brief Title
Ibuprofen and Renal Function in Premature Infants
Official Title
Ibuprofen and Renal Function in Premature Infants
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Maternite Regionale Universitaire
Collaborators
Central Hospital, Nancy, France, Ministere de la Sante et de la Protection Sociale, France

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Infants, Patent Ductus Arteriosus
Keywords
Premature Infants, Patent ductus arteriosus, Renal function, Ibuprofen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Primary Outcome Measure Information:
Title
Creatinine Clearance on day seven postnatally
Secondary Outcome Measure Information:
Title
Rate of ductus closure after treatment
Title
Mortality
Title
Rate of necrotizing enterocolitis
Title
Rate and severity of Intraventricular Hemorrhage
Title
Renal function maturation over 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Michel HASCOET, MD
Organizational Affiliation
University of Nancy, France
Official's Role
Study Director
Facility Information:
Facility Name
CHU
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
AP-HM (Néonatologie)
City
Marseille
ZIP/Postal Code
13000
Country
France
Facility Name
Maternite Regionale Universitaire
City
Nancy
ZIP/Postal Code
54042
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
15567009
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.
Results Reference
background
PubMed Identifier
21760564
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.
Results Reference
derived
PubMed Identifier
20368313
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.
Results Reference
derived
PubMed Identifier
19902266
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.
Results Reference
derived

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Ibuprofen and Renal Function in Premature Infants

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