Safety/Efficacy Study of Optimizing Ibuprofen Dosing to Achieve Higher PDA Closure Rates (OIDS)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by OSF Healthcare System.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
OSF Healthcare System
Information provided by:
OSF Healthcare System
ClinicalTrials.gov Identifier:
NCT00961753
First received: August 18, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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:
Further study details as provided by OSF Healthcare System:
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 |
|---|---|
| Experimental: Optimized Ibuprofen |
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
Other Name: neoprofen
|
| Active Comparator: Standard Ibuprofen |
Drug: Standard Ibuprofen
day of life 0-29 - 10,5, 5 mg/kg/dose at 24 hour intervals
Other Name: neoprofen
|
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 | Not yet recruiting |
| Peoria, Illinois, United States, 61637 | |
Sponsors and Collaborators
OSF Healthcare System
Investigators
| Principal Investigator: | James R Hocker, MD | OSF Healthcare System |
More Information
No publications provided
| Responsible Party: | James R. Hocker, MD, OSF Saint Francis Medical Center |
| ClinicalTrials.gov Identifier: | NCT00961753 History of Changes |
| Other Study ID Numbers: | Ibuprofendosingstudy |
| Study First Received: | August 18, 2009 |
| Last Updated: | August 18, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by OSF Healthcare System:
|
PDA Ibuprofen Preterm Neonate |
Additional relevant MeSH terms:
|
Ductus Arteriosus, Patent Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Congenital Abnormalities Ibuprofen Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 17, 2013