Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000266167
Ethics application status
Approved
Date submitted
16/02/2019
Date registered
21/02/2019
Date last updated
12/09/2022
Date data sharing statement initially provided
21/02/2019
Date results information initially provided
12/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Humidification weaning practices may impact infants born prematurely: a randomised controlled trial. (HUMIDITY Trial)
Scientific title
Humidification weaning practices may impact thermal stability in infants born prematurely: a randomised controlled trial. (HUMIDITY Trial)
Secondary ID [1] 297433 0
Nil known
Universal Trial Number (UTN)
Trial acronym
HUMIDITY Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypothermia in premature infants 311604 0
Hypernatraemia in premature infants 311605 0
Condition category
Condition code
Reproductive Health and Childbirth 310232 310232 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Humidification of an incubator= adding sterile water to an incubator/ baby's enclosed cot. Humidity is used to maintain temperature and electrolyte stability
Current Practice: Preterm infants aged less than 28 weeks gestation are currently placed in a humidified incubator (at 80% humidity) from birth to approximately seven days of age. 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 on day eight of life. On the first set of observations on day 8 (00:01) the bedside nurse will cease or wean humidification as per the protocol (of 5% per day).
In this study infants will be randomised to have their
-humidification ceased completely on day 8 after completing 7 days of humidification and care as usual.
- or to have their humidification weaned gradually (by 5% each day) from day 8 to day 14 when humidification will be ceased and care as usual.
Members of the research team will offer extensive education about this study prior to commencement of the study. Consistency is currently being achieved with all preterm infants (less than 28 weeks) being nursed in 80% for the full first seven days of life.
Research nurses allocated to this study, team leaders and the principal investigator will check each day to see which infants need to have their humidification levels changed at midnight and follow up with notes to the bedside nurse to ensure adherence to the protocol
Intervention code [1] 313684 0
Prevention
Intervention code [2] 313712 0
Treatment: Other
Comparator / control treatment
All premature infants less than 28 weeks gestation will be nursed in a humidified incubator for the first seven days of life. The humidity level to be administered will be 80%. The set and actual humidification level will be documented on the infant's observation sheet.
As standard practice is to cease all incubator humidification after 7 days, this will be the control group. Those premature infants randomised to the control arm will have their incubator humidification ceased at midnight on day 7 of life.
Control group
Active

Outcomes
Primary outcome [1] 319117 0
Infants will have their axillary temperature recorded with each set of cares ( standard practice is between 4 to 6 hourly) using a Welch Allyn SureTemp® Plus 692 portable, digital thermometer. This (the axillary temperature) will be documented on their observation sheet along with the set and actual humidification levels. Standard care is for an axillary temperature to be taken every 4-6 hours with each set of cares. This is standard until the infant no longer requires incubator care.
Timepoint [1] 319117 0
From day 8 to day 14 of life all premature infants enrolled in this study will have their axillary temperature taken with each set of cares. Cares are undertaken, by the bedside nurse, every 4 to 6 hours. This will be undertaken in from day 8 to day 14 of life.
Standard care is for an axillary temperature to be taken every 4-6 hours with each set of cares. This is standard until the infant no longer requires incubator care.
Secondary outcome [1] 367023 0
Infants born prematurely (less than 35 weeks) routinely have their serum sodium levels taken twice a week if they are receiving parenteral nutrition. Infants also have their serum sodium levels taken at least weekly if their serum sodium levels are normal. Other routine blood testing is undertaken at day 3, 7,10 and 14. If the infant has an arterial line insitu, then blood gas analysis ( which includes serum sodium levels) are undertaken twice each day. No additional blood testing will be completed for this study.
Timepoint [1] 367023 0
Infants born prematurely ( less than 35 weeks) routinely have their serum sodium levels taken twice a week if they are receiving parenteral nutrition. Infants also have their serum sodium levels taken at least weekly if their serum sodium levels are normal. Other routine blood testing is undertaken at day 3, 7,10 and 14. If the infant has an arterial line in situ, then blood gas analysis ( which includes serum sodium levels) are undertaken twice each day. No additional blood testing will be completed for this study. Blood results from the second week of life will be accessed from the pathology website



From day 8 to day 14 of life

Eligibility
Key inclusion criteria
Be aged greater than or equal to 23 weeks’ gestation but less than or equal to 27.6 weeks’ gestation,
Be no more than seven completed days of age at the time of recruitment,
Be nursed in an incubator,
Commence the planned intervention on day eight,
Be either inborn at the RBWH or out born,
Be expected to survive the first 14 days of life,
Have parents who can communicate effectively in the English language,
Have parents who will be provided with a patient information consent form (PICF) outlining the study at an appropriate time prior to day seven of life.
Minimum age
0 Days
Maximum age
7 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those with known or suspected chromosomal abnormalities,
Those with major congenital abnormalities,
Those with significant surgical conditions- specifically abdominal wall defects,
Those that need to be transferred out of the incubator to an open care system for ongoing management,
Those who have parents who have declined to permit participation,
Those infants considered too sick to seek parental consent.

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)
Sealed opaque envelopes will be utilised.
Being organised externally
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur by a computer-generated random number list that will be stratified by gestational age. This will ensure allocation is unpredictable. There will be two subgroups in each study arm greater than or equal to23 weeks to 25.6 weeks gestation and 26 weeks to less than or equal to 27.6 weeks
Being organised externally
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
An a priori retrospective chart audit conducted by the investigators of a similar population of extremely premature infants showed that about 70% of infants had an axillary temperature outside the normal range of 36.5°C-37.5°C at least twice during the second week of life. A sample size of 31 in each sub-group will be sufficient to detect a 50% decrease in this incidence of infant’s temperature being outside the normal range with 80% power (a = 0.05) within each sub-group. Allowing for recruitment failure and mortality (~10%) we planned to recruit 35 babies in each sub-group.

Analysis will be performed using the intention to treat principle, meaning all participants will be analysed in the study arm to which they were assigned. Continuous data will be presented as means and standard deviations, and categorical data as rates and percentages. For the primary outcome, the number of episodes outside the targeted normal temperature range in each group will be compared using Chi-squared or Fishers Extract test as appropriate. Subgroup analysis will be utilized to determine whether the proposed treatments were more effective for one age cohort than another.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/02/2019
Actual
16/04/2019
Date of last participant enrolment
Anticipated
28/02/2022
Actual
13/03/2022
Date of last data collection
Anticipated
7/03/2022
Actual
17/08/2022
Sample size
Target
140
Accrual to date
Final
140
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13166 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 25721 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 302002 0
Charities/Societies/Foundations
Name [1] 302002 0
Royal Brisbane and Women's Hospital Foundation Research Committee
Country [1] 302002 0
Australia
Primary sponsor type
Individual
Name
Gillion Noreiks
Address
C/- Grantley Stable Neonatal Intensive Care Unit
Level 5, Ned hanlon Building,
Butterfield Street, Herston,
Brisbane, QUeensland 4029
Country
Australia
Secondary sponsor category [1] 301786 0
None
Name [1] 301786 0
Address [1] 301786 0
Country [1] 301786 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302677 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 302677 0
Executive Suites, Lower Ground Floor
Dr James Mayne Building
Butterfield Street
Herston, Qld, 4029
Ethics committee country [1] 302677 0
Australia
Date submitted for ethics approval [1] 302677 0
26/11/2018
Approval date [1] 302677 0
13/02/2019
Ethics approval number [1] 302677 0

Summary
Brief summary
Humidified incubators are currently widely used in the care of premature infants to assist with thermal stability however, hypothermia continues to be a problem, as optimal thermal weaning practices remain unclear through lack of evidence
The primary aim of this trial will be to compare ceasing humidification at day 8 of life versus a gradual weaning protocol on maintaining body temperatures between 36.5°C – 37.5°C. We suspect that premature infants may benefit from being nursed in a humidified environment for longer than the standard one week which is currently provided.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91034 0
Ms Gillion Noreiks
Address 91034 0
C/-Grantley Stable Neonatal Intensive Care Unit
5th Floor, Ned Hanlon Building,
Royal Brisbane and Women's Hospital,
Butterfield Street, Herston, 4029
Queensland
Country 91034 0
Australia
Phone 91034 0
+61 736467846
Fax 91034 0
Email 91034 0
gill.noreiks@health.qld.gov.au
Contact person for public queries
Name 91035 0
Ms Gillion Noreiks
Address 91035 0
Grantley Stable Neonatal Intensive Care Unit
5th Floor, Ned Hanlon Building,
Royal Brisbane and Women's Hospital,
Butterfield Street, Herston, 4029
Brisbane
Country 91035 0
Australia
Phone 91035 0
+61 736467846
Fax 91035 0
Email 91035 0
gill.noreiks@health.qld.gov.au
Contact person for scientific queries
Name 91036 0
Ms Gillion Noreiks
Address 91036 0
Grantley Stable Neonatal Intensive Care Unit
5th Floor, Ned Hanlon Building,
Royal Brisbane and Women's Hospital,
Butterfield Street, Herston, 4029
Brisbane
Country 91036 0
Australia
Phone 91036 0
+61 736467846
Fax 91036 0
Email 91036 0
gill.noreiks@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Insufficient funding to maintain and secure collected data


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6640Study protocol  gill.noreiks@health.qld.gov.au
6641Informed consent form  gill.noreiks@health.qld.gov.au
6642Ethical approval  gill.noreiks@health.qld.gov.au



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.