Study Stopped
FDA drug recall on July 30, 2010
Safety/Efficacy Study of Optimizing Ibuprofen Dosing to Achieve Higher PDA Closure Rates
OIDS
Safety and Efficacy of an Optimized Ibuprofen Dosing Regimen Versus Standard Dosing for Pharmacologic Closure of Patent Ductus Arteriosus
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Aug 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 18, 2009
CompletedFirst Posted
Study publicly available on registry
August 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedJanuary 28, 2014
January 1, 2014
1.2 years
August 18, 2009
January 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PDA Closure
1-42 days of age
Secondary Outcomes (1)
renal function
1-30 days of age
Study Arms (2)
Optimized Ibuprofen
EXPERIMENTALStandard Ibuprofen
ACTIVE COMPARATORInterventions
day of life 0-3 - 10, 5, 5 mg/kg/dose at 24 hour intervals day of life 4-6 - 14, 7, 7 mg/kg/dose at 24 hour intervals day of life 7-29 - 20, 10, 10 mg/kg/dose at 24 hour intervals
day of life 0-29 - 10,5, 5 mg/kg/dose at 24 hour intervals
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital of Illinois at OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James R Hocker, MD
OSF Healthcare System
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
August 18, 2009
First Posted
August 19, 2009
Study Start
August 1, 2009
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
January 28, 2014
Record last verified: 2014-01