Ibuprofen and Renal Function in Premature Infants

Maternite Regionale Universitaire

Status and phase

Completed

Phase 4

Conditions

Premature Infants

Patent Ductus Arteriosus

Treatments

Drug: Ibuprofen

Study type

Interventional

Funder types

Other

Identifiers

NCT00217191

MRAP040833

PHRC2004:17-06

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

Under 28 days old

Volunteers

No Healthy Volunteers

Inclusion criteria