NCT00217191

Brief Summary

Purpose of the study:

  1. 1.To evaluate renal function maturation within the first month of life in very premature infants.
  2. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2004

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

September 19, 2006

Status Verified

September 1, 2006

First QC Date

September 14, 2005

Last Update Submit

September 18, 2006

Conditions

Premature InfantsPatent Ductus Arteriosus

Keywords

Premature InfantsPatent ductus arteriosusRenal functionIbuprofen

Outcome Measures

Primary Outcomes (1)

  • Creatinine Clearance on day seven postnatally

Secondary Outcomes (5)

  • Rate of ductus closure after treatment

  • Mortality

  • Rate of necrotizing enterocolitis

  • Rate and severity of Intraventricular Hemorrhage

  • Renal function maturation over 28 days

Interventions

IbuprofenDRUG

Eligibility Criteria

Age0 Years - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Gestational Age = 27 to 31 weeks
  • Postnatal age \< 48 hours
  • Parental Consent Obtained

You may not qualify if:

  • Renal malformation
  • Urinary tract infection
  • Renal Failure
  • Pulmonary Hypertension at echocardiography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU

Dijon, 21079, France

Location

AP-HM (Néonatologie)

Marseille, 13000, France

Location

Maternite Regionale Universitaire

Nancy, 54042, France

Location

Related Publications (4)

  • 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.

    PMID: 15567009BACKGROUND

  • 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.

    PMID: 21760564DERIVED

  • 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.

    PMID: 20368313DERIVED

  • 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.

    PMID: 19902266DERIVED

MeSH Terms

Conditions

Premature BirthDuctus Arteriosus, Patent

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Jean-Michel HASCOET, MD

    University of Nancy, France

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

September 1, 2004

Study Completion

September 1, 2006

Last Updated

September 19, 2006

Record last verified: 2006-09

Locations

FR(3)