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

OSF Healthcare System

Status and phase

Terminated

Phase 4

Conditions

Patent Ductus Arteriosus

Treatments

Drug: optimized ibuprofen

Drug: Standard Ibuprofen

Study type

Interventional

Funder types

Other

Identifiers

NCT00961753

Ibuprofendosingstudy

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

1 to 29 days old

Volunteers

No 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

Exclusion criteria