A multicentre, randomised controlled, non-inferiority trial, comparing high flow therapy with nasal continuous positive airway pressure as primary support for preterm infants with respiratory distress (the HIPSTER trial): study protocol
Calum T Roberts, Louise S Owen, Brett J Manley, Susan M Donath, Peter G Davis
BMJ OPEN | BMJ PUBLISHING GROUP | Published : 2015
INTRODUCTION: High flow (HF) therapy is an increasingly popular mode of non-invasive respiratory support for preterm infants. While there is now evidence to support the use of HF to reduce extubation failure, there have been no appropriately designed and powered studies to assess the use of HF as primary respiratory support soon after birth. Our hypothesis is that HF is non-inferior to the standard treatment--nasal continuous positive airway pressure (NCPAP)--as primary respiratory support for preterm infants. METHODS AND ANALYSIS: The HIPSTER trial is an unblinded, international, multicentre, randomised, non-inferiority trial. Eligible infants are preterm infants of 28-36(+6) weeks' gestati..View full abstract
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Awarded by National Health and Medical Research Council (NHMRC, Australia)
Awarded by NHMRC Centre for Research Excellence grant
The HIPSTER trial is supported by a National Health and Medical Research Council (NHMRC, Australia) project grant (No. 1079089), a NHMRC Centre for Research Excellence grant (No. 1060733), and a grant from the Royal Brisbane and Women's Hospital (Australia) Foundation.