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To demonstrate this with 90% power, we FK228 price require a sample size of 375 infants per group, 750 infants in total. We chose this margin of non-inferiority with consideration to the following factors: HF is already a widely accepted mode of respiratory support in many tertiary and non-tertiary neonatal units; Infants in whom HF treatment fails will receive NCPAP, and we hypothesise that this will ��rescue�� some of these infants from intubation; The primary outcome of this study is treatment failure, as opposed to an outcome like death or severe disability, when a lower margin of non-inferiority would be necessary; This non-inferiority margin was thought to be appropriate, and was agreed on by all neonatologists in all the participating centres, and by parent representatives consulted during the trial design phase. Statistical analysis The incidence of the primary outcome will be compared using risk difference and two-sided 95% CI. Planned subgroup analyses by GA strata will be performed for the primary outcome. Secondary outcomes will be compared using risk difference (95% CI) and ��2 tests, or the appropriate parametric (t test) or non-parametric (Mann-Whitney U) tests. Statistical analyses will be by intention to treat, conforming to the Consort reporting guidelines. Cost-effectiveness analysis will incorporate the costs of the device and of hospital care; a decision analysis will be constructed based on the primary outcome and associated hospital costs. Univariate and probabilistic sensitivity analyses will be conducted as a cost per additional treatment failure avoided for HF versus NCPAP. Ethics and dissemination Research ethics approval The HIPSTER trial has received multisite ethical approval from the relevant governing bodies for all participating centres. Recruitment and consent Written parental consent is required for all infants participating in the trial. Consent will be sought in the antenatal period when possible, at all sites. When antenatal consent is in place, infants will be randomised as soon as possible after meeting eligibility criteria. When antenatal consent has not been obtained, infants judged to require non-invasive respiratory support will receive standard treatment (NCPAP) until consent has been given. Families of infants meeting eligibility criteria will be approached at the earliest opportunity after birth, and before their infant has received 4 h of NCPAP treatment. Additionally, at the lead centre (The Royal Women's Hospital, Melbourne), the Human Research Ethics Committee (HREC) has approved a retrospective consent process. Eligible infants who have not been consented antenatally can be randomised as soon as they meet eligibility criteria.