Ibuprofen and Renal Function in Premature Infants

Condition(s) targeted: Premature Infants; Patent Ductus Arteriosus

Intervention: Ibuprofen (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Maternite Regionale Universitaire

Official(s) and/or principal investigator(s):
Jean-Michel HASCOET, MD, Study Director, Affiliation: University of Nancy, France

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.

Official title: Ibuprofen and Renal Function in Premature Infants

Study design: Treatment, Non-Randomized, Open Label, Active Control, Factorial Assignment, Safety Study

Primary outcome: Creatinine Clearance on day seven postnatally

Secondary outcome:

Rate of ductus closure after treatment

Mortality

Rate of necrotizing enterocolitis

Rate and severity of Intraventricular Hemorrhage

Renal function maturation over 28 days

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:

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.

Minimum age: N/A. Maximum age: 28 Days. Gender(s): Both.

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

Maternite Regionale Universitaire, NANCY 54042, France

AP-HM (Néonatologie), MARSEILLE 13000, France

CHU, DIJON 21079, France

Home page of the hospital

Related 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.

Starting date: September 2004
Ending date: September 2006
Last updated: September 18, 2006