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| Sponsor: | University of Utah |
|---|---|
| Collaborator: |
H. Lundbeck A/S |
| Information provided by: | University of Utah |
| ClinicalTrials.gov Identifier: | NCT00833365 |
Purpose
The primary objective is to evaluate the PDA closure rate of early vs. late use of Ibuprofen (Ibu). The investigators believe that early use of Ibu will have a higher PDA closure rate than later use of Ibu. Early use is defined as medication given before the infant reaches 96 hrs old. Late use is defined as medication given when infant is more than 96 hrs old.
The secondary objective is to measure the stress hormone and metabolic response (plasma catecholamines, glucose, and lactate) of neonates undergoing Ibu treatment of the PDA. The investigators believe that early ibuprofen will blunt the stress response greater than later use.
| Condition | Intervention |
|---|---|
|
Patent Ductus Arteriosus Prematurity |
Drug: Ibuprofen |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | Early vs. Late Use of Ibuprofen for PDA Closure and Pain/Stress Reduction |
| Estimated Enrollment: | 54 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Early treatment: Active Comparator
Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old
|
Drug: Ibuprofen
Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose
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|
Late treatment: Active Comparator
Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.
|
Drug: Ibuprofen
Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg
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Infants with birth weight at <1200gm and/or <28 weeks gestation who have been diagnosed with a PDA qualify for the study if there are no contraindications to treatment. Infants are randomized into treatment arms of <96 hrs old and >96 hrs old. Ibuprofen is given in the dosage of 10 mg/kg on initial dose, followed 24 hours later by 5 mg/kg dose and then 24 hours later another dose of 5 mg/kg. An echocardiogram will be done prior to treatment and then within 48 hours after treatment.
Stress response will be evaluated by drawing catecholamines, glucose, and lactate at one hour prior to initial dose of ibuprofen, and then at 1 and 6 hours post initial ibuprofen dose.
Eligibility| Ages Eligible for Study: | up to 96 Hours |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Carrie A Rau, RN | 801-581-5658 | carrie.rau@hsc.utah.edu |
| United States, Utah | |
| University of Utah | Recruiting |
| Salt Lake City, Utah, United States, 84132 | |
| Contact: Carrie Rau, RN 801-581-5658 carrie.rau@hsc.utah.edu | |
| Principal Investigator: Gary Chan, MD | |
| Principal Investigator: | Gary Chan, MD | University of Utah |
More Information
| Responsible Party: | University of Utah ( Dr. Gary Chan ) |
| Study ID Numbers: | 31394 |
| Study First Received: | January 29, 2009 |
| Last Updated: | January 12, 2010 |
| ClinicalTrials.gov Identifier: | NCT00833365 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
premature infants PDA ibuprofen |
|
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 |
