Brief Title
Safety/Efficacy Study of Optimizing Ibuprofen Dosing to Achieve Higher PDA Closure Rates
Official Title
Safety and Efficacy of an Optimized Ibuprofen Dosing Regimen Versus Standard Dosing for Pharmacologic Closure of Patent Ductus Arteriosus
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 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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
PDA Closure
Secondary Outcome
renal function
Condition
Patent Ductus Arteriosus
Intervention
optimized ibuprofen
Study Arms / Comparison Groups
Optimized Ibuprofen
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
10
Start Date
August 2009
Completion Date
October 2010
Primary Completion Date
October 2010
Eligibility 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
Gender
All
Ages
N/A - 29 Days
Accepts Healthy Volunteers
No
Contacts
James R Hocker, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00961753
Organization ID
Ibuprofendosingstudy
Responsible Party
Principal Investigator
Study Sponsor
OSF Healthcare System
Study Sponsor
James R Hocker, MD, Principal Investigator, OSF Healthcare System
Verification Date
January 2014