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

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Patent ductus arteriosus
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Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus

Brief Title

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

Official Title

Safety and Efficacy of an Optimized Ibuprofen Dosing Regimen Versus Standard Dosing for Pharmacologic Closure of Patent Ductus Arteriosus

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.

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.

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

PDA Closure

Secondary Outcome

 renal function

Condition

Patent Ductus Arteriosus

Intervention

optimized ibuprofen

Study Arms / Comparison Groups

 Optimized Ibuprofen
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

10

Start Date

August 2009

Completion Date

October 2010

Primary Completion Date

October 2010

Eligibility 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

Gender

All

Ages

N/A - 29 Days

Accepts Healthy Volunteers

No

Contacts

James R Hocker, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00961753

Organization ID

Ibuprofendosingstudy

Responsible Party

Principal Investigator

Study Sponsor

OSF Healthcare System

Study Sponsor

James R Hocker, MD, Principal Investigator, OSF Healthcare System

Verification Date

January 2014