Extrait

Background and study aims Hypoxic-ischemic encephalopathy (HIE) is a brain injury caused by lack of oxygen. Cooling (called whole body hypothermia [WBH]) is the standard treatment for newborn babies affected by HIE occurring at delivery. HIE is often associated with meconium aspiration syndrome (MAS), a severe respiratory problem that often occurs in newborns together with HIE. MAS occurs when a newborn baby breathes a mixture of meconium and amniotic fluid into the lungs around the time of delivery. The aim of this study is to clarify the effect of WBH on oxygenation and respiratory outcomes in MAS. Who can participate? Newborn babies with MAS born during 2006-2014 who were treated or not treated with WBH for HIE . What does the study involve? The clinical outcomes of babies who were treated with WBH are compared with the clinical outcomes of babies who were not treated with WBH. What are the possible benefits and risks of participating? There are neither benefits nor risks for participants. Where is the study run from? Eleven neonatal or pediatric intensive care units in Europe, Australia, South and North America. The study is being coordinated at the South Paris University Hospitals (France). When is the study starting and how long is it expected to run for? January 2006 to November 2015 Who is funding the study? Not provided at time of registration Who is the main contact? Prof. Daniele De Luca

Critère d'inclusion

• Meconium aspiration syndrome

Liens

• ictrp
• isrctn