Safety/Efficacy Study of Optimizing Ibuprofen Dosing to Achieve Higher PDA Closure Rates - Full Text View

Sponsor:	OSF Saint Francis Medical Center
Information provided by:	OSF Saint Francis Medical Center
ClinicalTrials.gov Identifier:	NCT00961753

Purpose

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.

Condition	Intervention	Phase
Patent Ductus Arteriosus	Drug: optimized ibuprofen Drug: Standard Ibuprofen	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title:	Safety and Efficacy of an Optimized Ibuprofen Dosing Regimen Versus Standard Dosing for Pharmacologic Closure of Patent Ductus Arteriosus

Resource links provided by NLM:

Drug Information available for: Ibuprofen

U.S. FDA Resources

Further study details as provided by OSF Saint Francis Medical Center:

Primary Outcome Measures:

PDA Closure [ Time Frame: 1-42 days of age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

renal function [ Time Frame: 1-30 days of age ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	138
Study Start Date:	August 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Optimized Ibuprofen: Experimental	Drug: optimized ibuprofen 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
Standard Ibuprofen: Active Comparator	Drug: Standard Ibuprofen day of life 0-29 - 10,5, 5 mg/kg/dose at 24 hour intervals

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

Ages Eligible for Study:	up to 29 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00961753

Contacts

Contact: James R Hocker, MD	309-655-2508 ext 3965	james.r.hocker@osfhealthcare.org
Contact: Julie Kasap, PharmD	309-265-8559	julie.l.kasap@osfhealthcare.org

Locations

United States, Illinois
Children's Hospital of Illinois at OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637

Sponsors and Collaborators

OSF Saint Francis Medical Center

Investigators

Principal Investigator:

James R Hocker, MD

OSF Saint Francis Medical Center

More Information

No publications provided

Responsible Party:	OSF Saint Francis Medical Center ( James R. Hocker, MD )
Study ID Numbers:	Ibuprofendosingstudy
Study First Received:	August 18, 2009
Last Updated:	August 18, 2009
ClinicalTrials.gov Identifier:	NCT00961753 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by OSF Saint Francis Medical Center:

PDA
Ibuprofen
Preterm
Neonate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Ibuprofen
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Cardiovascular Abnormalities
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents

Therapeutic Uses
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Congenital Abnormalities
Central Nervous System Agents
Heart Defects, Congenital
Ductus Arteriosus, Patent

ClinicalTrials.gov processed this record on February 08, 2010