Echocardiographically Guided Versus Standard Ibuprofen Treatment for Patent Ductus Arteriosus

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
• Treatments: Ibuprofen

Criteria

Inclusion Criteria:

• Preterm infants with a gestational age lower than 37 weeks of gestational age

• PDA ≥ 1.5 mm

• No contraindication to receive ibuprofen

• Informed consent signed.

Exclusion Criteria:

• Life-threatening congenital defects

• Congenital heart disease

• Contraindication for ibuprofen administration such as oligoanuria < 1cc/kg/h or recent severe intraventricular bleeding (IVH grade III) or creatinine serum level > 1.5 mg/dl or potential intestinal ischemia.

• Informed consent refused