neonatal ecmo study of temperature (nest) - a randomised controlled trial新生儿医学界研究的温度(巢)u2014u2014一个随机对照试验.pdfVIP

Field et al. BMC Pediatrics 2010, 10:24 /1471-2431/10/24 S T U D Y P R O T O C O L Open Access Study protocol Neonatal ECMO Study of Temperature (NEST) - a randomised controlled trial 1 2 3 4 5 5 David J Field* , Richard Firmin , Denis V Azzopardi , Frances Cowan , Edmund Juszczak , Peter Brocklehurst and the NEST Study Group Abstract Background: Existing evidence indicates that once mature neonates with severe cardio-respiratory failure become eligible for Extra Corporeal Membrane Oxygenation (ECMO) their chances of intact survival are doubled if they actually receive ECMO. However, significant numbers survive with disability. NEST is a multi-centre randomised controlled trial designed to test whether, in neonates requiring ECMO, cooling to 34°C for the first 48 to 72 hours of their ECMO course leads to improved later health status. Infants allocated to the control group will receive ECMO at 37°C throughout their course, which is currently standard practice around the world. Health status of both groups will be assessed formally at 2 years corrected age. Methods/Design: All infants recruited to the study will be cared for in one of the four United Kingdom (UK) ECMO centres. Babies who are thought to be eligible will be assessed by the treating clinician who will confirm eligibility, ensure that consent has been obtained and then randomise the baby using a web based system, based at the National Perinatal Epidemiology Unit (NPEU) Clinical Trials Unit. Trial registration. Babies allocated ECMO without cooling will receive ECMO at 37°C ± 0.2°C. Babies allocated ECMO with cooling will be managed at 34°C ± 0.2°C for up to 72 hours from the start of their ECMO run. The minimum duration of cool