drugset / Trial / NCT01593163
Echocardiographically Guided Versus Standard Ibuprofen Treatment for Patent Ductus Arteriosus
Phase 3
Completed
49 enrolled
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
RandomizedParallel-groupTriple-blindTreatment
Summary
Patent ductus arteriosus (PDA) is a very common condition in immature newborn babies and it has been associated to morbidity and mortality. Ibuprofen is the drug of choice for PDA treatment according to the last version of the Cochrane review. Nowadays the best dose regimen for ibuprofen remains uncertain. The investigators aim to perform a randomized controlled clinical trial to assess whether echocardiographically guided PDA ibuprofen treatment versus standard treatment could reduce the number of doses of ibuprofen without increasing the reopening rate and reducing the side effects associated to this medication.
Timeline
- Start
- 2009-05
- Primary completion
- 2010-03
- Completion
- 2010-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ibuprofen | Small molecule | 5 mg/kg | — |