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Trial registered on ANZCTR


Registration number
ACTRN12625000726459
Ethics application status
Approved
Date submitted
10/02/2025
Date registered
8/07/2025
Date last updated
8/07/2025
Date data sharing statement initially provided
8/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Justifying humidification management options for infants delivered extremely premature- when and why? A randomised controlled trial. (Y HUMIDIFY).
Scientific title
Evaluating the impact of three different incubator humidification management strategies on thermal and sodium stability and skin condition in infants delivered extremely premature- when and why? A randomised controlled trial.
Secondary ID [1] 313923 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Y HUMIDIFY trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypernatraemia in extremely premature infants 337886 0
Skin integrity/ skin injuries in extremely premature infants 337887 0
Hyponatraemia in extremely premature infants 336617 0
Hypothermia in extremely premature infants 336615 0
Hyperthermia in extremely premature infants 336616 0
Condition category
Condition code
Reproductive Health and Childbirth 333118 333118 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Humidification of an incubator- adding sterile water into an incubator (baby's enclosed cot) to increase the ambient relative humidity within. Current practice: Premature infants aged less than 28 weeks gestation are currently placed in a humidified incubator (at 80% humidity) from birth to 168 hours of life (seven full days). The bedside nursing clinician caring for the infant each shift will be responsible for administering and maintaining humidification into the incubator. Both the set and actual humidification levels are recorded by the bedside nurse every hour. Humidification is ceased at 168 hours of life and care as usual.
In this study, infants will be nursed in 80% incubator humidity from birth and then if parents’ consent to their participation in the trial, they will be randomised to one of three different treatment groups/ arms for managing their incubator humidification
-Arm 1 (the control arm) incubator humidification will be ceased at 168 hours (7 days) of life (current practice) and care as usual
-Arm 2 (an intervention arm) incubator humidification will be ceased at 96 hours (4 days) of life and care as usual
-Arm 3 ( an intervention arm) incubator humidification will be weaned by 10% daily from 96 hours of life to 168 hours of life and then ceased with care as usual.
Members of the research team will offer extensive education about this study to neonatal intensive care staff prior to commencement of the study. Consistency is currently being achieved with all premature infants born less than 28 weeks' gestation being nursed in 80% incubator humidity for the first 168 hours of life.
Research nurses allocated to this study, team leaders and/or the principal investigator will check each day to see which infants need their humidification levels changed and follow up with written notes to the bedside nurse to ensure adherence to the protocol. They will also determine if any new admissions meet the eligibility criteria to participate in the trial. Parental consent will be sought to permit eligible premature infants to participate in this trial. If parents do not which for their infant to participate in this trial the infant will be nursed in 80% incubator humidity for 168 hours as this is current practice. The maximum number of participants that will be asked to participate in this study is 378.
To ensure compliance to the protocol and adherence to the intervention the following is planned:
Each individual bedside clinician will be provided with one-on-one education about the trial and the details of each intervention will be explained in detail
Individual and group education sessions and in-service will be provided to improve compliance with the protocol and permit questions to be answered.
Beside each enrolled infant will be a folder containing
• the protocol
• the enrolment schema describing the three treatment arms
• the relevant documentation and cot cards for the treatment arm the infant has been randomised to.
Plus research staff will check each day to ensure adherence to the protocol by reviewing the bedside observation chart, reminding the bedside nurse of the planned intervention.
Team leaders on each shift will examine the eligible participants randomisation and ensure the proposed intervention is being adhered to.
Intervention code [1] 330511 0
Prevention
Intervention code [2] 330512 0
Treatment: Other
Comparator / control treatment
All premature infants born less than 28 weeks gestation will be nursed in a humidified incubator for the first 168 hours (7 days) of life. The humidity level to be administered will be set at 80%. The set and actual humidification level will be documented on the infant's observation sheet every hour. As standard practice is to cease incubator humidification at 168 hours of life (7 days), this will be the control group. Those premature infants randomised to the control arm will have their incubator humidification ceased at 168 hours of life.
Control group
Active

Outcomes
Primary outcome [1] 340661 0
Episodes of temperature/ thermal instability- episodes of hypothermia (defined as a temperature < 36.5 degrees Celsius
Timepoint [1] 340661 0
From admission to 168 hours of life all premature infants enrolled in this study will have their axillary temperature recorded with each set of cares as a minimum. All cares will be undertaken by the bedside nurse every 4-6 hours. This is standard until the infant no longer requires incubator care. This measurement is not affected by the management arm the infant is randomised to.
Primary outcome [2] 340822 0
Episodes of temperature/ thermal instability- episodes of hyperthermia (defined as a temperature > 37.5 degrees Celsius).
Timepoint [2] 340822 0
From admission to 168 hours of life all premature infants enrolled in this study will have their axillary temperature recorded with each set of cares as a minimum. All cares will be undertaken by the bedside nurse every 4-6 hours. This is standard until the infant no longer requires incubator care. This measurement is not affected by the management arm the infant is randomised to.
Secondary outcome [1] 444718 0
Episodes of hyponatraemia defined as < 135 mEq/L
Timepoint [1] 444718 0
Any blood test results collected in the first 168 hours of life will be accessed from the pathology website. No additional blood testing will be required or performed as part of this study.
Secondary outcome [2] 445170 0
Episodes of hypernatraemia defined as >145 mEq/L
Timepoint [2] 445170 0
Any blood test results collected in the first 168 hours of life will be accessed from the pathology website. No additional blood testing will be required or performed as part of this study.
Secondary outcome [3] 444719 0
Post natal skin injuries defined as any skin injury acquired from a single or combination of mechanical forces.
Timepoint [3] 444719 0
Skin condition is documented each shift as standard practice. Wound charts, photos, written descriptions and the use of the bedside chart of skin integrity are commonly used to describe and define the presence of skin injury. Assessment will be documented at least twice a day by the bedside nurse for the first 168 hours of life

Eligibility
Key inclusion criteria
Premature infants aged < 28 weeks' gestation at the time of birth
No more than 96 hours of age at the time of recruitment to allow for randomization and timely intervention commencement.
Either inborn at the Royal Brisbane and Women's Hospital or out-born (as long as they are admitted within 12 hours from birth)
Minimum age
0 Hours
Maximum age
168 Hours
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those with known or suspected chromosomal abnormalities
Those with known or suspected congenital abnormalities
Those with known or suspected inherited skin conditions i.e. Epidermolysis Bullosa
Those with significant surgical conditions- specifically abdominal wall defects
Those infants not meeting the inclusion criteria

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)
Randomization will occur via a randomization model which has been set up in REDCap and will be stratified by gestational age. Randomization will occur via the computer at the time of registration and consent to participate.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratification will occur based on two gestational age groups: Less than or equal to 25.6 weeks and 26-27 .6 weeks gestation. A computer software program will generate the random sequence to ensure allocation will be unpredictable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/07/2025
Actual
Date of last participant enrolment
Anticipated
24/07/2028
Actual
Date of last data collection
Anticipated
7/08/2028
Actual
Sample size
Target
378
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 28121 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 44325 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 318407 0
Charities/Societies/Foundations
Name [1] 318407 0
Royal Brisbane and Women's Hospital Foundation Research Committee
Country [1] 318407 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital, Metro North Queensland Health
Address
Country
Australia
Secondary sponsor category [1] 320798 0
None
Name [1] 320798 0
Address [1] 320798 0
Country [1] 320798 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317035 0
Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 317035 0
Ethics committee country [1] 317035 0
Australia
Date submitted for ethics approval [1] 317035 0
28/11/2024
Approval date [1] 317035 0
27/05/2025
Ethics approval number [1] 317035 0

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

Contacts
Principal investigator
Name 139782 0
Ms Gillion Noreiks
Address 139782 0
C/- Grantley Stable Neonatal Intensive Care Unit. 5th Floor Ned Hanlon Building, Royal Brisbane and Women's Hospital, Butterfield Street, Herston, 4029, Brisbane, Queensland
Country 139782 0
Australia
Phone 139782 0
+61 736467846
Fax 139782 0
Email 139782 0
[email protected]
Contact person for public queries
Name 139783 0
Gillion Noreiks
Address 139783 0
C/- Grantley Stable Neonatal Intensive Care Unit. 5th Floor Ned Hanlon Building, Royal Brisbane and Women's Hospital, Butterfield Street, Herston, 4029, Brisbane, Queensland
Country 139783 0
Australia
Phone 139783 0
+61 736467846
Fax 139783 0
Email 139783 0
[email protected]
Contact person for scientific queries
Name 139784 0
Gillion Noreiks
Address 139784 0
C/- Grantley Stable Neonatal Intensive Care Unit. 5th Floor Ned Hanlon Building, Royal Brisbane and Women's Hospital, Butterfield Street, Herston, 4029, Brisbane, Queensland
Country 139784 0
Australia
Phone 139784 0
+61 736467846
Fax 139784 0
Email 139784 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Insufficient funding to maintain and secure collected data



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    approval 070225.pdf
Study protocol    112949 Y HUMIDIFY Protocol V1.2 25 March 2025 (1) (1).docx
Informed consent form    Y HUMIDIFY PICF V.1.1 6.3.2025 (2).docx
Ethical approval    amendment approval 270525.pdf
Ethical approval    Ament 1 Cvr HREC YHUMIDITY 26.3.25 (2).pdf
Ethical approval    Letter of Amendment approval 10.04.25.pdf
Ethical approval    112949 RBWH SSA Approval Letter.pdf


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.