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

Stopped early · Phase 4

Conditions studied: Patent Ductus Arteriosus

In brief

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.

Key facts

Study ID

NCT00961753

Run by

OSF Healthcare System

People needed

10

Starts

2009-08-01

Expected to finish

2010-10-01

Last updated by the study team

2014-01-28

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital of Illinois at OSF Saint Francis Medical Center — Peoria, Illinois, United States

Full record on ClinicalTrials.gov

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