Ibuprofen and Renal Function in Premature Infants

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00217191

Enrollment

120

Registered

2005-09-22

Start date

2004-09-30

Completion date

2006-09-30

Last updated

2006-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patent Ductus Arteriosus, Premature Infants

Keywords

Premature Infants, Patent ductus arteriosus, Renal function, Ibuprofen

Brief 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.

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.

Interventions

DRUGIbuprofen

Study design

Allocation

NON_RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

0 Years to 28 Days

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

Design outcomes

Primary

Measure	Time frame
Creatinine Clearance on day seven postnatally	—

Secondary

Measure	Time frame
Rate of ductus closure after treatment	—
Mortality	—
Rate of necrotizing enterocolitis	—
Rate and severity of Intraventricular Hemorrhage	—
Renal function maturation over 28 days	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026