Clinical Trials Logo
  1. Home
  2. Patent Ductus Arteriosus
  3. NCT00217191
  4. Details
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
See also
  Status Clinical Trial Phase
Recruiting NCT04986839 - PAIR (Paracetamol and Ibuprofen Research) Pilot Trial Phase 2/Phase 3
Recruiting NCT03648437 - Paracetamol And Ibuprofen/Indomethacin in Closing Patent Ductus Arteriosus Phase 1
Completed NCT04126512 - Timing of Surgical PDA Ligation and Neonatal Outcomes
Not yet recruiting NCT06045130 - PUFAs in Preterm Infants
Not yet recruiting NCT02894970 - A New Device for Measuring of Lung Photoplethysmography and Pulmonic Arterial Saturation N/A
Completed NCT03551600 - Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus
Completed NCT02621528 - Lifetech CeraFlex™ Post-Market Surveillance Study N/A
Terminated NCT03982342 - Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants N/A
Completed NCT01479218 - Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus N/A
Completed NCT00795990 - Timing for the Medical Treatment of Patent Ductus Arteriosus in Preterm Infants N/A
Withdrawn NCT00554307 - Brain, Gut and Kidney Blood Flow During Medical Closure of PDA N/A
Terminated NCT00802685 - Timing of PDA Closure and Respiratory Outcome in Premature Infants N/A
Completed NCT03723889 - Patent Ductus Arteriosus and Splanchnic Oxygenation at First Feed
Recruiting NCT04397913 - Population Pharmacokinetics and Dosage Individualization of Paracetamol and Ibuprofen in Children With PDA
Completed NCT02750228 - PDA Post NICU Discharge
Recruiting NCT02220270 - Hyperion™ International Registry Trial N/A
Completed NCT01593163 - Echocardiographically Guided Versus Standard Ibuprofen Treatment for Patent Ductus Arteriosus Phase 3
Completed NCT03277768 - Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.
Completed NCT03022253 - Platelet Transfusion for Treatment of Patent Ductus Arteriosus in Thrombocytopenic Preterm Neonates Phase 3
Recruiting NCT02380040 - Plethismographic Perfusion Index in Neonates N/A

External Links