Ibuprofen and Renal Function in Premature Infants

Sponsor

Maternite Regionale Universitaire (Other)

Overall Status

Completed

CT.gov ID

NCT00217191

Collaborator

Central Hospital, Nancy, France (Other), Ministere de la Sante et de la Protection Sociale, France (Other)

120

Enrollment

Locations

Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Premature Infants Patent Ductus Arteriosus	Drug: Ibuprofen	Phase 4

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.

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Ibuprofen and Renal Function in Premature Infants

Study Start Date :

Sep 1, 2004

Study Completion Date :

Sep 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 28 Days

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU	Dijon	France	21079
2	AP-HM (Néonatologie)	Marseille	France	13000
3	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

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00217191

Other Study ID Numbers:

MRAP040833
PHRC2004:17-06

First Posted:

Sep 22, 2005

Last Update Posted:

Sep 19, 2006

Last Verified:

Sep 1, 2006

Keywords provided by , ,

Premature Infants

Patent ductus arteriosus

Renal function

Ibuprofen

Additional relevant MeSH terms:

Premature Birth

Ductus Arteriosus, Patent

Ibuprofen

Study Results

No Results Posted as of Sep 19, 2006