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.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12624001332516

Acronym

HUM-TE

Enrollment

Registered

2024-11-01

Start date

2025-05-22

Completion date

2027-09-30

Last updated

2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

No minimum to 6 Hours

Healthy volunteers

Inclusion criteria

1. Preterm infants, born less than 27 weeks gestation 2. Age less than or equal to 6 hours of age 3. Inborn infants (infants born at the participating hospital) 4. Single or multiple birth (birth of more than one baby from a single pregnancy, e.g., twins)

Exclusion criteria

1. Antenatal or postnatal major congenital abnormalities 2. Confirmed genetic disorders affecting the brain, neurodevelopment and/or the skin 3. Life expectancy of less than 6 hours 4. Outborn infants

Outcome results