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Completed

NCT Number: NCT00217191

Ibuprofen and Renal Function in 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.

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Key information

Conditions

Premature Infants Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Ductus Arteriosus, Patent Female Urogenital Diseases and Pregnancy Complications Heart Defects, Congenital Heart Diseases Obstetric Labor Complications Obstetric Labor, Premature Patent Ductus Arteriosus Pregnancy Complications Premature Birth Urogenital Diseases

Age range

0 year–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU, Dijon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibuprofen

Drug

Primary outcomes

  1. Creatinine Clearance on day seven postnatally

Secondary outcomes

  1. Rate of ductus closure after treatment

  2. Mortality

  3. Rate of necrotizing enterocolitis

  4. Rate and severity of Intraventricular Hemorrhage

  5. Renal function maturation over 28 days

Sponsors and collaborators

Lead sponsor

Maternite Regionale Universitaire

Other

Collaborators

  • Central Hospital, Nancy, France
  • Ministere de la Sante et de la Protection Sociale, France

Registry information

Important dates

Study start
2004
Study completion
2006
First posted
Sep 22, 2005
Registry last updated
Sep 19, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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