neoprom neonatal oxygenation prospective meta-analysis collaboration study protocolneoprom新生儿氧化前瞻性分析合作研究协议.pdfVIP

Askie et al. BMC Pediatrics 2011, 11:6 /1471-2431/11/6 STUDY PROTOCOL Open Access NeOProM: Neonatal Oxygenation Prospective Meta-analysis Collaboration study protocol 1* 2 3 4 5,6 7,8 Lisa M Askie , Peter Brocklehurst , Brian A Darlow , Neil Finer , Barbara Schmidt , William Tarnow-Mordi , for the NeOProM Collaborative Group1 Abstract Background: The appropriate level of oxygenation for extremely preterm neonates (28 weeks’ gestation) to maximise the greatest chance of survival, without incurring significant morbidity, remains unknown. Infants exposed to lower levels of oxygen (targeting oxygen saturations of 90%) in the first weeks of life are at increased risk of death, cerebral palsy, patent ductus arteriosus, pulmonary vascular resistance and apnoea, whilst those maintained in higher levels of oxygen (targeting oxygen saturations of 90%) have been reported to have greater rates of morbidity including retinopathy of prematurity and chronic lung disease. In order to answer this clinical dilemma reliably, large scale trial evidence is needed. Methods/Design: To detect a small but important 4% increase in death or severe disability in survivors, over 5000 neonates would need to be recruited. As extreme prematurity affects 1% of births, such a project undertaken by one trial group would be prohibitively lengthy and expensive. Hence, the Neonatal Oxygenation Prospective Meta-analysis (NeOProM) Collaboration has been formed. A prospective meta-analysis (PMA) is one where studies are identified, evaluated, and determined to be eligible before the results of any included studies are known or published, thereby avoiding some of the potential biases inherent in standard,