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Echocardiographically Guided Versus Standard Ibuprofen Treatment for Patent Ductus Arteriosus

NCT01593163 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2012-05-08

No results posted yet for this study

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.

Conditions

  • Patent Ductus Arteriosus

Interventions

DRUG

Ibuprofen EchoG

Infants in the experimental group (echoG treatment) received additional doses of ibuprofen only if PDA was still ≥ 1.5 mm at the time of the corresponding ibuprofen dose.

DRUG

Standard ibuprofen treatment

Infants received 3 doses of ibuprofen at 24-hour intervals, independently of ductal size, as long as additional doses were not contraindicated.

Sponsors & Collaborators

  • Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

    lead OTHER

Principal Investigators

  • María Carmen Bravo, PhD MD · Department of Neonatology, La Paz University Hospital

  • Fernando Cabañas, PhDMD · Department of Neonatology, La Paz University Hospital

  • Joan Riera, Bio-Engineer · Department of Neonatology, La Paz University Hospital

  • Elia Pérez-Fernández · Division of Statistics, La Paz University Hospital. Madrid, Spain.

  • José Quero, PhDMD · Department of Neonatology, La Paz University Hospital. Madrid, Spain.

  • Jesús Pérez-Rodríguez, PhDMD · Department of Neonatology, La Paz University Hospital. Madrid, Spain.

  • Adelina Pellicer, PhDMD · Department of Neonatology, La Paz University Hospital. Madrid, Spain.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01593163 on ClinicalTrials.gov