Status:
COMPLETED
High-dose Ibuprofen for Patent Ductus Arteriosus (PDA) in Preterm Infant
Lead Sponsor:
University of Florence
Conditions:
Ductus Arteriosus, Patent
Eligibility:
All Genders
12-24 years
Phase:
PHASE2
PHASE3
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 ...
Detailed Description
The patency of ductus arteriosus (PDA) is a frequent complication in preterm infants suffering from respiratory distress syndrome (RDS), and 60% to 70% of preterm infants of \<28 weeks' gestation rece...
Eligibility Criteria
Inclusion
- Gestational age \<29 weeks; an echocardiographic evidence of significant PDA; an age of 12 to 24 hours; and RDS necessitating respiratory support.
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Exclusion
- 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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Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01243996
Start Date
June 1 2008
End Date
October 1 2010
Last Update
November 19 2010
Active Locations (1)
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1
Careggi University Hospital, Division of Neonatology
Florence, Italy, 50141