Safety/Efficacy Study of Optimizing Ibuprofen Dosing to Achieve Higher PDA Closure Rates (OIDS)

This study has been terminated.
(FDA drug recall on July 30, 2010)
Sponsor:
Information provided by (Responsible Party):
James Hocker, OSF Healthcare System
ClinicalTrials.gov Identifier:
NCT00961753
First received: August 18, 2009
Last updated: January 25, 2014
Last verified: January 2014
  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 ]

Enrollment: 10
Study Start Date: August 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Illinois
Children's Hospital of Illinois at OSF Saint Francis Medical Center
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 Hocker, M.D., OSF Healthcare System
ClinicalTrials.gov Identifier: NCT00961753     History of Changes
Other Study ID Numbers: Ibuprofendosingstudy
Study First Received: August 18, 2009
Last Updated: January 25, 2014
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 September 18, 2014