Introduction Nasal high-flow (nHF) therapy is a popular mode of respiratory support for newborn infants. Evidence for nHF use is predominantly from neonatal intensive care units (NICUs). There are no randomised trials of nHF use in non-tertiary special care nurseries (SCNs). We hypothesise that nHF is non-inferior to nasal continuous positive airway pressure (CPAP) as primary support for newborn infants with respiratory distress, in the population cared for in non-tertiary SCNs. Methods and analysis The HUNTER trial is an unblinded Australian multicentre, randomised, non-inferiority trial. Infants are eligible if born at a gestational age ≥31 weeks with birth weight ≥1200 g and admitted to a participating non-tertiary SCN, are <24 hours old at randomisation and require non-invasive respiratory support or supplemental oxygen for >1 hour. Infants are randomised to treatment with either nHF or CPAP. The primary outcome is treatment failure within 72 hours of randomisation, as determined by objective oxygenation, apnoea or blood gas criteria or by a clinical decision that urgent intubation and mechanical ventilation, or transfer to a tertiary NICU, is required. Secondary outcomes include incidence of pneumothorax requiring drainage, duration of respiratory support, supplemental oxygen and hospitalisation, costs associated with hospital care, cost-effectiveness, parental stress and satisfaction and nursing workload. Ethics and dissemination Multisite ethical approval for the study has been granted by The Royal Children’s Hospital, Melbourne, Australia (Trial Reference No. 34222), and by each participating site. The trial is currently recruiting in eight centres in Victoria and New South Wales, Australia, with one previous site no longer recruiting. The trial results will be published in a peer-reviewed journal and will be presented at national and international conferences. Trial registration number Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12614001203640; pre-results.
The requirement for prospective consent in clinical trials in acute settings may result in samples unrepresentative of the study population, potentially altering study findings. However, using retrospective consent may raise ethical issues. We assessed whether using retrospective consent affected recruitment, participant characteristics, and outcomes within a randomized controlled trial.We conducted a secondary analysis of a randomized trial, which compared nasal high flow (nHF) with nasal continuous positive airway pressure (CPAP) for primary respiratory support in preterm infants. In Era 1, all infants were consented prospectively; in Era 2, retrospective consent was available. We assessed inclusion rates of eligible infants, demographic data, and primary trial outcome (treatment failure within 72 hours).In Era 1, recruitment of eligible infants was lower than in Era 2: 111 of 220 (50%) versus 171 of 209 (82%), P < .001; intrapartum antibiotic administration was lower: 23 of 111 (21%) versus 84 of 165 (51%), P < .001; full courses of antenatal steroids were higher: 86 of 111 (78%) versus 103 of 170 (61%), P = .004; and more infants received pre-randomization CPAP: 77 of 111 (69%) versus 48 of 171 (28%), P < .001. In Era 1, nHF failure (15 of 56, 27%) and CPAP failure (14 of 55, 26%) rates were similar, P = .9. In Era 2, failure rates differed: 24 of 85 (28%) nHF infants versus 13 of 86 (15%) CPAP infants, P = .04. The χ2 interaction test was nonsignificant (P = .20).The use of retrospective consent resulted in greater recruitment and differences in risk factors between eras. Using retrospective consent altered the study sample, which may be more representative of the whole population. This may improve scientific validity but requires further ethical evaluation.
Skin-to-skin care (SSC) has proven benefits in preterm infants, but increased hypoxic and bradycardic events have been reported. This may make clinicians hesitant to recommend SSC as standard care. We hypothesised that regional cerebral oxygenation (rStO2) measured with near infrared spectroscopy is not worse during SSC compared with standard incubator care.Prospective, observational, non-inferiority study.Single tertiary perinatal centre in Australia.Forty preterm infants (median (IQR) 30.6 (29.1-31.7) weeks' gestation) not receiving respiratory support were studied on day 14 (8-38).Recordings during 90 min of incubator care, followed by 90 min of SSC. Each infant acted as their own control and caregivers were blinded to the rStO2 measurements.The primary outcome was the mean difference in rStO2 between SSC and incubator care. The prespecified margin of non-inferiority was -1.5%. Secondary outcomes included heart rate (HR), peripheral oxygen saturation (SpO2), time in quiet sleep, temperature and hypoxic (SpO2 <80% for >5 s) or bradycardic events (HR <80 bpm for >5 s) and time spent in cerebral hypoxia (rStO2<55%) and hyperoxia (rStO2>85%).Mean (SD) rStO2 was lower during SSC compared with incubator care: 73.6 (6.0)% vs 74.8 (4.6)%, mean difference (95% CI) 1.3 (2.2 to 0.4)%. HR was 5 bpm higher, SpO2 1% lower and time in quiet sleep 24% longer during SSC. Little evidence of a difference was observed in temperature. The number of hypoxic or bradycardic events as well as the proportion of time spent in cerebral hypoxia and hyperoxia was very low in both periods.Mean rStO2 was marginally lower during SSC without observed differences in hypoxic or bardycardic events but an increase in time spent in quiet sleep.This trial is linked to Australian New Zealand Clinical Trials Registry: identifier 12616000240448. It was registered pre-results.
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