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

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

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 ]

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 ]

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


Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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Please refer to this study by its identifier: NCT01243996

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Carlo Dani, MD, University of Florence Identifier: NCT01243996     History of Changes
Other Study ID Numbers: CD63-1
Study First Received: November 17, 2010
Last Updated: November 18, 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
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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 processed this record on September 21, 2017