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

Phase 4

Terminated

• Conditions: Patent Ductus Arteriosus
• Interventions: Drug: optimized ibuprofen; Drug: Standard Ibuprofen

• Registration Number: NCT00961753
• Lead Sponsor: OSF Healthcare System

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 Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-18
• Study First Submitted QC: 2009-08-18
• Study First Posted: 2009-08-19
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-25
• Last Update Posted: 2014-01-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Optimized Ibuprofen	optimized ibuprofen	-
Standard Ibuprofen	Standard Ibuprofen	-

Primary Outcome Measures

Name	Time	Method
PDA Closure	1-42 days of age

Secondary Outcome Measures

Name	Time	Method
renal function	1-30 days of age

Trial Locations

Locations (1)

Children's Hospital of Illinois at OSF Saint Francis Medical Center; 🇺🇸 Peoria, Illinois, United States