High-dose Ibuprofen for Patent Ductus Arteriosus (PDA) in Preterm Infant

This study has been completed.
Sponsor:
Information provided by:
University of Florence
ClinicalTrials.gov Identifier:
NCT01243996
First received: November 17, 2010
Last updated: November 18, 2010
Last verified: July 2010
  Purpose

The investigators hypothesized that the early treatment of PDA with ibuprofen doses higher than those actually recommended might increase the closure rate in preterm infants with gestational age <29 weeks without increasing the occurrence of associated adverse effects. To assess this hypothesis the investigators planned a multicenter randomized controlled study to compare the effectiveness of the current ibuprofen regimen to that of a high-dose regimen in closing PDA.


Condition Intervention Phase
Ductus Arteriosus, Patent
Drug: Ibuprofen
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: High-dose Ibuprofen for Patent Ductus Arteriosus in Extremely Preterm Infants: a Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by University of Florence:

Primary Outcome Measures:
  • Successful rate in closing PDA of ibuprofen administered at high or standard dose. [ Time Frame: Between 84 and 96 hours of life ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Effectiveness of a second high dose ibuprofen course; correlation between peak plasma level of ibuprofen and PDA closure; mortality or BPD among survivors, incidence of ICH, PVL, ROP, NEC, sepsis, and length of stay in hospital. [ Time Frame: Hospital discharge ] [ Designated as safety issue: Yes ]

Enrollment: 70
Study Start Date: June 2008
Study Completion Date: October 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Infant treated with high dose ibuprofen Drug: Ibuprofen
Treatment with high (20-10-10 mg/kg/day)or standard dose(10-5-5 mg/kg/day) ibuprofen
Other Name: Pedea, Orphan Europe, Paris, France

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 24 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Gestational age <29 weeks; an echocardiographic evidence of significant PDA; an age of 12 to 24 hours; and RDS necessitating respiratory support.

-

Exclusion Criteria: Major congenital anomalies; life-threatening infection or hydrops fetalis; pulmonary hypertension; death before the conclusion of the first course of ibuprofen; urine output below 1 ml per kilogram of body weight per hour during the preceding 12 hours (with the exception of the first dose); a serum creatinine concentration of >1.5 mg/dL (129 μmol per liter); a platelet count of <50,000/mm3; a tendency to bleed, as revealed by hematuria, blood in the endotracheal aspirate, gastric aspirate, or stools, and oozing from puncture sites.

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243996

Locations
Italy
Careggi University Hospital, Division of Neonatology
Florence, Italy, 50141
Sponsors and Collaborators
University of Florence
Investigators
Study Chair: Carlo Dani, MD University of Florence, Italy
  More Information

No publications provided by University of Florence

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carlo Dani, MD, University of Florence
ClinicalTrials.gov Identifier: NCT01243996     History of Changes
Other Study ID Numbers: CD63-1
Study First Received: November 17, 2010
Last Updated: November 18, 2010
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by University of Florence:
Patent ductus arteriosus, ibuprofen, preterm infants

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Defects, Congenital
Heart Diseases
Ibuprofen
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014