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Trial registered on ANZCTR


Registration number
ACTRN12624001332516
Ethics application status
Approved
Date submitted
11/10/2024
Date registered
1/11/2024
Date last updated
1/11/2024
Date data sharing statement initially provided
1/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing clinical effects of incubator HUMidity at Two levels in Extreme Preterms trial
Scientific title
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.
Secondary ID [1] 313105 0
CTC0399
Universal Trial Number (UTN)
Trial acronym
HUM-TE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extremely premature infants 335352 0
Condition category
Condition code
Reproductive Health and Childbirth 331941 331941 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 329676 0
Treatment: Other
Comparator / control treatment
80% 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.
Control group
Active

Outcomes
Primary outcome [1] 339543 0
Any episode of hypernatremia (serum sodium =>150 mmol/L) in the first 3 days after randomisation.
Timepoint [1] 339543 0
In the first 3 days after randomisation
Primary outcome [2] 339717 0
Mean of all serum sodium concentration (mmol/L) in the first 3 days after randomisation
Timepoint [2] 339717 0
In the first 3 days after randomisation
Secondary outcome [1] 440398 0
Number of postpartum skin injuries
Timepoint [1] 440398 0
During the first 14 days after birth
Secondary outcome [2] 440399 0
Late onset sepsis
Timepoint [2] 440399 0
In the first 21 days after birth.
Secondary outcome [3] 440401 0
Any brain injury before hospital discharge
Timepoint [3] 440401 0
From birth until hospital discharge
Secondary outcome [4] 440402 0
Survival until hospital discharge
Timepoint [4] 440402 0
From birth until hospital discharge
Secondary outcome [5] 440543 0
Safety of the intervention, defined as rates of Suspected Unexpected Serious Adverse Reaction (SUSAR) attributed to 95% incubator humidity versus 80% humidity
Timepoint [5] 440543 0
In the first 21 days after birth.
Secondary outcome [6] 440544 0
(Process Evaluation Objective)
Context, uptake and acceptability of starting incubator humidity at 95%
Timepoint [6] 440544 0
Beginning, middle and end of trial
Secondary outcome [7] 440545 0
(Process Evaluation Objective)
Parent experience measure
Timepoint [7] 440545 0
Day 4 and at 1 month after birth
Secondary outcome [8] 440606 0
Tertiary Outcome (Hypothesis Generating)
Any hypernatraemia >145 mmol/L in the first 7 days after birth
Timepoint [8] 440606 0
In the first 7 days after birth
Secondary outcome [9] 440607 0
Tertiary Outcome (Hypothesis Generating)
Mean of all sodium concentration (mmol/L) for the first 7 days after birth
Timepoint [9] 440607 0
In the first 7 days after birth
Secondary outcome [10] 440608 0
Tertiary Outcome (Hypothesis Generating)
Highest sodium concentration (mmol/L) in the first 7 days after birth
Timepoint [10] 440608 0
In the first 7 days after birth
Secondary outcome [11] 440609 0
Tertiary Outcome (Hypothesis Generating)
Maximum total daily fluid intake (ml/kg/day) in the first 3 and 7 days after birth
Timepoint [11] 440609 0
In the first 3 and 7 days after birth
Secondary outcome [12] 440610 0
Tertiary Outcome (Hypothesis Generating)
Mean of daily total fluid intake (ml/kg/day) for the first 3 and 7 days after birth
Timepoint [12] 440610 0
For the first 3 and 7 days after birth
Secondary outcome [13] 440611 0
Tertiary Outcome (Hypothesis Generating)
Bronchopulmonary dysplasia
Timepoint [13] 440611 0
36 weeks post-menstrual age
Secondary outcome [14] 440612 0
Tertiary Outcome (Hypothesis Generating)
Necrotising enterocolitis
Timepoint [14] 440612 0
From birth until hospital discharge
Secondary outcome [15] 440613 0
Tertiary Outcome (Hypothesis Generating)
Patent ductus arteriosus (PDA) requiring surgical closure
Timepoint [15] 440613 0
From birth until hospital discharge
Secondary outcome [16] 440614 0
Tertiary Outcome (Hypothesis Generating)
Advanced retinopathy of prematurity (ROP) treated with laser surgery and/or intravitreal injection of anti-vascular endothelial growth factor
Timepoint [16] 440614 0
From birth until hospital discharge
Secondary outcome [17] 440615 0
Tertiary Outcome (Hypothesis Generating)
Accidental dislodgement of essential monitoring or treatment interface
Timepoint [17] 440615 0
In the first 3 days after birth
Secondary outcome [18] 440616 0
Tertiary Outcome (Hypothesis Generating)
Maximum percentage weight loss after birth
Timepoint [18] 440616 0
From birth until hospital discharge
Secondary outcome [19] 440617 0
Tertiary Outcome (Hypothesis Generating)
Change in body weight on days 3, 7 and 14 after randomisation
Timepoint [19] 440617 0
Days 3, 7 and 14 after randomisation
Secondary outcome [20] 440618 0
Tertiary Outcome (Hypothesis Generating)
Skin integrity assessment
Timepoint [20] 440618 0
Days 3, 7, 14 and 28 after randomisation
Secondary outcome [21] 440621 0
Tertiary Outcome (Hypothesis Generating)
Trans-epidermal water loss (TEWL) and skin hydration
Timepoint [21] 440621 0
Days 3, 7, 14 and 28 after randomisation
Secondary outcome [22] 440622 0
Tertiary Outcome (Hypothesis Generating)
Skin integrity around kangaroo care (KC)
Timepoint [22] 440622 0
In the first four weeks after birth
Secondary outcome [23] 440623 0
Tertiary Outcome (Hypothesis Generating)
Association between the number of skin injuries during the first 14 days after randomisation and the risk of death.
Timepoint [23] 440623 0
The first 14 days after randomisation
Secondary outcome [24] 440624 0
Tertiary Outcome (Hypothesis Generating)
Association between the characteristics of skin injury in the first 14 days after randomisation and the risk of death
Timepoint [24] 440624 0
The first 14 days after randomisation

Eligibility
Key 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)
Minimum age
No limit
Maximum age
6 Hours
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Antenatal or postnatal major congenital abnormalities
2. Confirmed genetic disorders
3. Life expectancy of less than 6 hours
4. Outborn infants

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted blocks. Randomisation will be stratified by gestational age (<25+0 and 25+0–26+6/7 weeks), hospital site and incubator type with 1:1 allocation, with all babies of multiple births being allocated to the same treatment.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/02/2025
Actual
Date of last participant enrolment
Anticipated
30/09/2027
Actual
Date of last data collection
Anticipated
29/02/2028
Actual
Sample size
Target
308
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 317550 0
Government body
Name [1] 317550 0
Australian Government Department of Health and Aged Care - Medical Research Future Fund
Country [1] 317550 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 319856 0
None
Name [1] 319856 0
Address [1] 319856 0
Country [1] 319856 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316261 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 316261 0
Ethics committee country [1] 316261 0
Australia
Date submitted for ethics approval [1] 316261 0
30/08/2024
Approval date [1] 316261 0
24/09/2024
Ethics approval number [1] 316261 0
2024/ETH01930

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137318 0
Dr Pranav Jani
Address 137318 0
c/o HUM-TE, NHMRC Clinical Trials Centre, University of Sydney, Camperdown NSW 2050
Country 137318 0
Australia
Phone 137318 0
+61 2 8890 8911
Fax 137318 0
Email 137318 0
pranav.jani@sydney.edu.au
Contact person for public queries
Name 137319 0
Sarah Chinchen
Address 137319 0
c/o HUM-TE, NHMRC Clinical Trials Centre, University of Sydney, Camperdown NSW 2050
Country 137319 0
Australia
Phone 137319 0
+61 2 95625380
Fax 137319 0
Email 137319 0
hum-te.study@sydney.edu.au
Contact person for scientific queries
Name 137320 0
Pranav Jani
Address 137320 0
c/o HUM-TE, NHMRC Clinical Trials Centre, University of Sydney, Camperdown NSW 2050
Country 137320 0
Australia
Phone 137320 0
+61 2 8890 8911
Fax 137320 0
Email 137320 0
pranav.jani@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Participant data supporting the publication results and participant data relating to primary outcomes
When will data be available (start and end dates)?
Data are available 6 months after publication.
Data are available for an indefinite time.
Available to whom?
Data are potentially available to:
- Researchers from not-for-profit organisations
- Commercial organisations
- Other

All data requests will be considered by the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement.
Available for what types of analyses?
Any type of analysis and will be assessed on a case-by-case basis.
How or where can data be obtained?
Please contact the study team at hum-te.study@sydney.edu.au


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.