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

NCT ID: NCT00961753

Last Updated: 2014-01-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2010-10-31

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.

Conditions

Patent Ductus Arteriosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Optimized Ibuprofen

Group Type: EXPERIMENTAL

optimized ibuprofen

Intervention Type: DRUG

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

Standard Ibuprofen

Group Type: ACTIVE_COMPARATOR

Standard Ibuprofen

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Standard Ibuprofen

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

Intervention Type: DRUG

Other Intervention Names

neoprofen; neoprofen

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 29 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OSF Healthcare System

OTHER

Sponsor Role: lead

Responsible Party

James Hocker

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James R Hocker, MD

Role: PRINCIPAL_INVESTIGATOR

OSF Healthcare System

Locations

Children's Hospital of Illinois at OSF Saint Francis Medical Center

Peoria, Illinois, United States

Countries

United States

Other Identifiers

Ibuprofendosingstudy

Identifier Type: -

Identifier Source: org_study_id