RecruitingACTRN12624001332516

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.


Sponsor

The University of Sydney

Enrollment

308 participants

Start Date

May 22, 2025

Study Type

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

Sex: Both males and femalesMax Age: 6 Hourss

Plain Language Summary

Simplified for easier understanding

Extremely premature babies (born before 27 weeks of pregnancy) lose a lot of water through their fragile skin, which can cause dangerous levels of sodium in the blood. Keeping these babies in a humid environment inside an incubator helps protect their skin and prevents this dehydration. Currently, most Australian hospitals set incubator humidity at 80%, while hospitals in Japan routinely use 95%. Neither level has been tested in a rigorous clinical trial. The HUM-TE study is a randomised trial comparing 80% and 95% incubator humidity in extremely preterm babies, to see whether higher humidity reduces the risk of dangerously high blood sodium, skin breakdown, serious brain bleeds, and infection. The trial also includes a sub-study examining the effect of humidity on skin barrier function. Your baby may be eligible if they were born before 27 weeks of pregnancy, are less than 6 hours old, and were born at a participating hospital. Babies with major congenital abnormalities, known genetic disorders affecting the brain or skin, or a life expectancy of less than 6 hours are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

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)

Westmead Hospital - Westmead

NSW,QLD, Australia

Liverpool Hospital - Liverpool

NSW,QLD, Australia

Gold Coast University Hospital - Southport

NSW,QLD, Australia

The Canberra Hospital - Garran

NSW,QLD, Australia

Royal Hospital for Women - Randwick

NSW,QLD, Australia

John Hunter Children's Hospital - New Lambton

NSW,QLD, Australia

Royal Prince Alfred Hospital - Camperdown

NSW,QLD, Australia

Nepean Hospital - Kingswood

NSW,QLD, Australia

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ACTRN12624001332516