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Trial registered on ANZCTR


Registration number
ACTRN12623000722695
Ethics application status
Approved
Date submitted
16/06/2023
Date registered
5/07/2023
Date last updated
23/06/2024
Date data sharing statement initially provided
5/07/2023
Date results information initially provided
23/06/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Removing smAll BaBies from Incubators to coT (RABBIT) - A pilot study
Scientific title
Assessing the impact of novel weaning criteria for transferring premature babies from incubators to cot - A pilot study
Secondary ID [1] 309915 0
Nil known
Universal Trial Number (UTN)
Trial acronym
RABBIT Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
premature baby's temperatures 330387 0
growth restricted babies 330388 0
low birth weight 330389 0
Condition category
Condition code
Reproductive Health and Childbirth 327226 327226 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Neonatal nurses will assess the weaning criteria. The anticipated time to assess each neonate will be 10 minutes per neonate. Babies will be assessed as able to be weaned when reaching 34 weeks or weight of 1400g (if older).
Prior to weaning neonates' axillary temps will be assessed for 48 hrs and if over or equal to 36.7 degrees C and crib temp average less than or equal to 27 degrees C, the baby can be weaned to a cot.
The babies' temperatures will be closely monitored for 7 days from the point of weaning into a cot.
All details will be recorded onto an excel chart and in the medical records.
Intervention code [1] 326347 0
Prevention
Comparator / control treatment
The control/historical group is standard/usual care and practice for weaning out of incubators. The practice is currently based on individual the clinician's assessment of the baby's readiness to wean into a cot - no specific age or weight criteria have been identified.

The control/historical group data was collected from a 2 year period spanning from June 2019 to May 2021.
Control group
Historical

Outcomes
Primary outcome [1] 335112 0
Monitoring axilla temperature (36.5C or more) for 7 days after transitioning from the incubator, using a digital thermometer
Timepoint [1] 335112 0
7 days post commencement of weaning into cot
Secondary outcome [1] 423093 0
Any change in weight assessed using digital weighing scales
Timepoint [1] 423093 0
Discharge from neonatal unit
Secondary outcome [2] 423440 0
Any change in head circumference assessed by tape measure
Timepoint [2] 423440 0
Discharge from neonatal unit
Secondary outcome [3] 423441 0
Length of stay will be accessed from the electronic Record of Intensive Care (eRIC) medical history
Timepoint [3] 423441 0
Discharge from neonatal unit
Secondary outcome [4] 423442 0
Failure to weaning (defined as – going back into the incubator within a week of weaning) due to other causes (eg: sepsis, hypoglycaemia, apnoea). This data will be sourced from the electronic Record of Intensive Care (eRIC) medical history
Timepoint [4] 423442 0
within 7 days of weaning into cot

Eligibility
Key inclusion criteria
Born at less than 34 weeks gestation or weighing less than 1400g at birth
Informed parental consent
Needing incubator care for at least 72 hours
Minimum age
No limit
Maximum age
4 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Major congenital anomalies
No parental consent

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
As this is a pilot study, no formal sample size is needed. Based on a previous cohort of babies over the last year (June 2020 – June 2021) we anticipate enrolling 100 babies.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/02/2023
Date of last participant enrolment
Anticipated
1/02/2025
Actual
3/12/2023
Date of last data collection
Anticipated
28/02/2025
Actual
31/12/2023
Sample size
Target
100
Accrual to date
Final
63
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24940 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 40591 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 314098 0
Hospital
Name [1] 314098 0
Nepean Hospital
Country [1] 314098 0
Australia
Primary sponsor type
Hospital
Name
Nepean Hospital
Address
Derby St,
Kingswood
NSW 2747
Country
Australia
Secondary sponsor category [1] 316015 0
None
Name [1] 316015 0
Address [1] 316015 0
Country [1] 316015 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313236 0
Nepean Blue Mountains Local Health District Human Research Ethics Committee
Ethics committee address [1] 313236 0
Derby St,
Kingswood
NSW 2747
Ethics committee country [1] 313236 0
Australia
Date submitted for ethics approval [1] 313236 0
16/06/2021
Approval date [1] 313236 0
05/12/2022
Ethics approval number [1] 313236 0
2021/ETH00829
Ethics committee name [2] 313237 0
Western Sydney University Research Committee
Ethics committee address [2] 313237 0
Locked Bag 1797
Penrith NSW
2751
Ethics committee country [2] 313237 0
Australia
Date submitted for ethics approval [2] 313237 0
10/08/2021
Approval date [2] 313237 0
17/08/2021
Ethics approval number [2] 313237 0
RH14587

Summary
Brief summary
This pilot study would be implemented at Nepean Hospital on low birth weight babies born at less than 34 weeks or weighing less than 1400g at birth and to assess whether there is sufficient evidence for justification for weaning them more rapidly into a cot from a humidicrib once they reach 34 weeks gestation and or 1400g weight. There is a need to further investigate these outcomes in Australia as neonatal intensive care nurses and medical staff use their own judgement on an ad hoc basis to determine when premature and small for gestational age babies can be weaned into a cot and may be arbitrarily delaying their progress. Currently there is no evidence pertaining to this practice with babies weighing between 1400g to 1600g and this project addresses this gap.

The hypothesis is that stable low birth weight babies who qualify for the enrolment criteria can successfully tolerate weaning once they consistently demonstrate a stable body temperature at the lowest incubator air temperature and this will have no impact on their temperature stability, weight gain and facilitate faster discharge from hospital.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127438 0
Ms Ria Koppen
Address 127438 0
Neonatal Services
Level 6 Tower A
Nepean Hospital
Derby St
Kingswood
NSW
2747
Country 127438 0
Australia
Phone 127438 0
+61 2 47343490
Fax 127438 0
Email 127438 0
ria.koppen@health.nsw.gov.au
Contact person for public queries
Name 127439 0
Ms Ria Koppen
Address 127439 0
Neonatal Services
Level 6 Tower A
Nepean Hospital
Derby St
Kingswood
NSW
2747
Country 127439 0
Australia
Phone 127439 0
+61 2 47343490
Fax 127439 0
Email 127439 0
ria.koppen@health.nsw.gov.au
Contact person for scientific queries
Name 127440 0
Ms Ria Koppen
Address 127440 0
Neonatal Services
Level 6 Tower A
Nepean Hospital
Derby St
Kingswood
NSW
2747
Country 127440 0
Australia
Phone 127440 0
+61 2 47343490
Fax 127440 0
Email 127440 0
ria.koppen@health.nsw.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
As this is a pilot study data will be analysed predominantly to guide a future randomised control trial


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19461Ethical approval  ria.koppen@health.nsw.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.