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

Sponsor

OSF Healthcare System (Other)

Overall Status

Terminated

CT.gov ID

NCT00961753

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Patent Ductus Arteriosus	Drug: optimized ibuprofen Drug: Standard Ibuprofen	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Aug 1, 2009

Actual Primary Completion Date :

Oct 1, 2010

Actual Study Completion Date :

Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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 Names: neoprofen
Active Comparator: Standard Ibuprofen	Drug: Standard Ibuprofen day of life 0-29 - 10,5, 5 mg/kg/dose at 24 hour intervals Other Names: neoprofen

Arm

Intervention/Treatment

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 Names:

neoprofen

Active Comparator: Standard Ibuprofen

Drug: Standard Ibuprofen

day of life 0-29 - 10,5, 5 mg/kg/dose at 24 hour intervals

Other Names:

neoprofen

Outcome Measures

Primary Outcome Measures

PDA Closure [1-42 days of age]

Secondary Outcome Measures

renal function [1-30 days of age]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 29 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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