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Additional file 1 of Intratracheal budesonide mixed with surfactant to increase survival free of bronchopulmonary dysplasia in extremely preterm infants: statistical analysis plan for the international, multicenter, randomized PLUSS trial
journal contribution
posted on 2023-11-07, 04:41 authored by Kate L Francis, Christopher J D McKinlay, C Omar F Kamlin, Jeanie L Y Cheong, Peter A Dargaville, Jennifer A Dawson, Lex W Doyle, Susan E Jacobs, Peter G Davis, Susan M Donath, Brett J ManleyAdditional file 1. Table S1. Example Table of reasons for using the “BPD algorithm” to diagnose BPD. Table S2. Example Table of additional death data to be reported.
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National Health and Medical Research Council Chiesi Farmaceutici
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statistical analysis plansafe prophylactic therapiesminimizing systemic sequelaeidentity link functionanticipated event rateinvasive respiratory supporttwo treatment groupsporactant alfa aloneextremely preterm infantsearly childhood healthalpha error 0alive without bpdsecondary outcomes includefound intratracheal budesonidepoorer neurodevelopmental outcomesbinary primary outcomeprimary outcome ).increase survival freeintratracheal budesonide mixedkg first interventionprimary outcomeporactant alfarespiratory outcomesintratracheal budesonideneurodevelopmental outcomessurvival freeprimary objectiveintratracheal administrationinclude costfirst weekbinary regressionterm outcomesrelative increaseadverse neurodevelopmentalabsolute increaseprematurity ).doses ).ventilated infantsthin catheterstudy withdrawalsshort termseveral smallsample sizereceiving nonrandomized trialsrandomized trialpublished separatelyprovide 90promising therapypluss trialpluss aimedphysiological bpdmechanically ventilatedendotracheal tubecontrol armsclinical decisionci ),bronchopulmonary dysplasiabpd priorbpd ),binomial distribution48 h25 mg200 mg1060 infants1038 infants100 mg10 %),
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