Comparing clinical effects of incubator HUMidity at Two levels in Extreme Preterms trial
Does initial incubator humidity of 95% versus 80% reduce hypernatraemia, skin injury, sepsis and brain damage in extremely preterm infants? Establishing a world-first, pragmatic, randomised comparative effectiveness trial.
The University of Sydney
308 participants
May 22, 2025
Interventional
Conditions
Summary
Without adequate ambient humidity, extremely preterm babies lose water through their skin, causing dehydration and hypernatraemia (high blood sodium concentration), which is associated with death, brain injury and disability. Skin water loss and hypernatraemia are reduced by increasing incubator humidity. However, there is worldwide variation in practice due to lack of high-quality clinical trials. Clinicians in Japan routinely use 95% incubator humidity compared to 80% in Australia. The HUM-TE study hypothesis is that in extremely preterm infants, initial incubator humidity of 95% compared with 80% reduces the risk of any hypernatraemia (serum sodium >=150 mmol/L) and/or mean sodium concentration in the first three days after randomisation and reduces the risk of skin injury, sepsis, IVH and brain damage. The concurrent process evaluation will explore context, uptake, acceptability and parent experience of starting incubator humidity at 95%. Skin integrity substudies will assess the effects of incubator humidity on skin barrier function.
Eligibility
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Interventions
95% initial incubator humidity. Commenced as soon as possible upon admission to the neonatal intensive care unit (NICU) and within 6 hours after birth and continued for 72 hours from randomisation. Adherence to the randomised intervention will be monitored through data reported in the study's electronic CRF and the patient's medical record.
Locations(8)
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ACTRN12624001332516