Status:
TERMINATED
Safety/Efficacy Study of Optimizing Ibuprofen Dosing to Achieve Higher PDA Closure Rates
Lead Sponsor:
OSF Healthcare System
Conditions:
Patent Ductus Arteriosus
Eligibility:
All Genders
1-29 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine if increasing the ibuprofen dose will increase the likelihood of closing the patent ductus arteriosus in premature babies.
Detailed Description
Failure to close the PDA in premature neonates in a timely fashion can lead to pulmonary over-circulation and systemic under-circulation. The PDA often fails to close using currently approved Ibuprofe...
Eligibility Criteria
Inclusion
- All neonates (0-29 days old) less than or equal to 33 post-menstrual age at time of PDA diagnosis requiring nasal CPAP or mechanical ventilation
- Echo confirmed PDA with a transductal diameter of 1.5 mm or greater and demonstrating a left-to-right shunt
- Signed informed consent
Exclusion
- Presence of: ductal-dependent congenital heart disease, pulmonary hypertension,
- Active bleeding (including Grade 3 or 4 IVH)
- Platelet count \< 100,000
- Coagulopathy
- Suspected NEC
- Suspected perforation
- Creatinine \> 1.5
- Hyperbilirubinemia requiring exchange transfusion
- Hypotension requiring pressor support
- Life-threatening congenital malformation
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00961753
Start Date
August 1 2009
End Date
October 1 2010
Last Update
January 28 2014
Active Locations (1)
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1
Children's Hospital of Illinois at OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637