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

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ClinicalTrials.gov Identifier: NCT01243996
Recruitment Status : Completed
First Posted : November 19, 2010
Last Update Posted : November 19, 2010
Sponsor:
Information provided by:
University of Florence

Brief Summary:
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 or disease Intervention/treatment Phase
Ductus Arteriosus, Patent Drug: Ibuprofen Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: High-dose Ibuprofen for Patent Ductus Arteriosus in Extremely Preterm Infants: a Randomized Controlled Study
Study Start Date : June 2008
Primary Completion Date : May 2010
Study Completion Date : October 2010


Arm Intervention/treatment
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



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

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: November 19, 2010    Key Record Dates
Last Update Posted: November 19, 2010
Last Verified: July 2010

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

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