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Ibuprofen and Renal Function in Premature Infants

NCT ID: NCT00217191

Last Updated: 2006-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2006-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Premature Infants Patent Ductus Arteriosus

Keywords

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Premature Infants Patent ductus arteriosus Renal function Ibuprofen

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Ibuprofen

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role collaborator

Ministere de la Sante et de la Protection Sociale, France

UNKNOWN

Sponsor Role collaborator

Maternite Regionale Universitaire

OTHER

Sponsor Role lead

Principal Investigators

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Jean-Michel HASCOET, MD

Role: STUDY_DIRECTOR

University of Nancy, France

Locations

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CHU

Dijon, , France

Site Status

AP-HM (Néonatologie)

Marseille, , France

Site Status

Maternite Regionale Universitaire

Nancy, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 15567009 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21760564 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20368313 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19902266 (View on PubMed)

Other Identifiers

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PHRC2004:17-06

Identifier Type: -

Identifier Source: secondary_id

MRAP040833

Identifier Type: -

Identifier Source: org_study_id