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NCT00217191 Clinical Trial

Ibuprofen and Renal Function in Premature Infants

Patent Ductus Arteriosus Clinical Trial

Official title:
Ibuprofen and Renal Function in Premature Infants

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00217191
Other study ID # MRAP040833
Secondary ID PHRC2004:17-06
Status Completed
Phase Phase 4
First received September 14, 2005
Last updated September 18, 2006
Start date September 2004
Est. completion date September 2006

Study information
Verified date September 2006
Source Maternite Regionale Universitaire
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date September 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 28 Days
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ibuprofen

Locations
Country Name City State
France CHU Dijon
France AP-HM (Néonatologie) Marseille
France Maternite Regionale Universitaire Nancy

Sponsors (3)
Lead Sponsor Collaborator
Maternite Regionale Universitaire Central Hospital, Nancy, France, Ministere de la Sante et de la Protection Sociale, France

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Creatinine Clearance on day seven postnatally
Secondary Rate of ductus closure after treatment
Secondary Mortality
Secondary Rate of necrotizing enterocolitis
Secondary Rate and severity of Intraventricular Hemorrhage
Secondary Renal function maturation over 28 days
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Completed NCT03277768 - Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.
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