Safety/Efficacy Study of Optimizing Ibuprofen Dosing to Achieve Higher PDA Closure Rates
Information source: OSF Saint Francis Medical Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Patent Ductus Arteriosus
Intervention: optimized ibuprofen (Drug); Standard Ibuprofen (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: OSF Saint Francis Medical Center Official(s) and/or principal investigator(s):
James R Hocker, MD, Principal Investigator, Affiliation: OSF Saint Francis Medical Center
Overall contact:
James R Hocker, MD, Phone: 309-655-2508, Ext: 3965, Email: james.r.hocker@osfhealthcare.org
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.
Clinical Details
Official title: Safety and Efficacy of an Optimized Ibuprofen Dosing Regimen Versus Standard Dosing for Pharmacologic Closure of Patent Ductus Arteriosus
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Primary outcome: PDA Closure
Secondary outcome: renal function
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 Ibuprofen dosing regimens, and surgical closure becomes necessary.
Ibuprofen clearance in premature neonates is significantly correlated with postnatal age,
increasing rapidly over time. Hirt et al. published and optimized dosing scheme for preterm
neonates based on pharmacokinetic and pharmacodynamic data. We aim to use this dosing
regimen in the clinical setting to determine if increased rates of pharmacologic PDA closure
can be achieved.
Eligibility
Minimum age: N/A.
Maximum age: 29 Days.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
James R Hocker, MD, Phone: 309-655-2508, Ext: 3965, Email: james.r.hocker@osfhealthcare.org
Children's Hospital of Illinois at OSF Saint Francis Medical Center, Peoria, Illinois 61637, United States
Additional Information
Starting date: August 2009
Ending date: December 2011
Last updated: August 18, 2009
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