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

Phase 4TerminatedNCT00961753

OSF Healthcare System10 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Patent Ductus Arteriosus

Interventions

optimized ibuprofenDRUG

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 IbuprofenDRUG

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

Eligibility

Sex: ALLMin age: 1 DayMax age: 29 Days

Medical Language ↔ Plain English

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

Locations (1)

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

Peoria, Illinois, United States

Outcomes

Primary Outcomes

PDA Closure

Time frame: 1-42 days of age

Secondary Outcomes

renal function

Time frame: 1-30 days of age

Data from ClinicalTrials.gov

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