CompletedPhase 3

Echocardiographically Guided Versus Standard Ibuprofen Treatment for Patent Ductus Arteriosus

Spain49 participantsStarted 2009-05

Plain-language 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.

Who can participate

Age range1 Month

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

PDA re-opening rate

Timeframe: Infants will be followed for the duration of hospital stay in the Newborn Unit, an expected average of 4-8 weeks

Trial details

NCT IDNCT01593163

SponsorFundacion para la Investigacion Biomedica del Hospital Universitario la Paz

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-03

View on ClinicalTrials.gov More Patent Ductus Arteriosus trials