Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000167864
Ethics application status
Approved
Date submitted
18/12/2020
Date registered
18/02/2021
Date last updated
15/08/2023
Date data sharing statement initially provided
18/02/2021
Date results provided
15/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
BEMPU Temperature Device Study for Low Birth Weight Babies
Scientific title
Investigating the effect of a temperature monitoring device on hypothermia-related escalation of care in low birth weight babies: a randomised controlled trial.
Secondary ID [1] 303049 0
Nil
Universal Trial Number (UTN)
Trial acronym
BEMPU Temp study (BEMPU Temp watch study)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neonatal Hypothermia 320115 0
Condition category
Condition code
Reproductive Health and Childbirth 318055 318055 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mothers/ parents who are allocated to this group will receive a BEMPU TempWatch for their newborn baby to wear for up to 28 days, and educated on providing skin-to-skin contact for their babies if hypothermia is indicated by the audio-visual alarm. They will also receive the standard neonatal care whilst in hospital and provided the standard information for temperature maintenance upon discharge home.
The BEMPU TempWatch is placed on the newborn baby's wrist where it provides continuous temperature monitoring for up to 28 days, and will trigger an audio-visual alarm if the baby's temperature drops below 36 degrees Celsius. The duration of the intervention is for a maximum of up to 28 days (based on battery life and size of baby's wrist) Education for providing skin-to-skin contact will be provided to parents by midwifery educators. Regular checks will be used to monitor adherence to the intervention. Newborn babies will be receiving standard neonatal care, which includes regular temperature monitoring, weight checks and blood sugar monitoring. They will receive the standard neonatal care whilst in hospital (as described in the comparator/control field).
Intervention code [1] 319334 0
Treatment: Devices
Comparator / control treatment
Standard neonatal care for newborn including immediate skin-to-skin contact for one hour after delivery and with every feed. The newborn is wrapped in a blanket and has a beanie placed on their head as soon as possible after birth, and feeding is ideally commenced within the first hour after delivery. The temperature of the neonate is measured every hour for the first four hours and low birth weight babies have their temperature measured before each feed (roughly every 3 hours) along with their other vital signs and blood glucose levels, until they are at least 24 hours of age and their temperature has been within the normal range for 24 hours. If the neonate has an axillary temperature between 36.0 – 36.5°C, conservative measures such as increased layers of clothing and skin-to-skin contact are implemented. If the neonate has an axillary temperature <36.0°C, they are admitted to the special care nursery and placed in an isolette until their temperature stabilises between 36.5 – 37.5°C. Parents are provided with an information sheet regarding temperature monitoring upon discharge. All neonates are offered a domiciliary visit by a midwife within the first few days after discharge whilst babies who weighed <10th centile at birth are initially cared for under the Hospital in the Home program.
Control group
Active

Outcomes
Primary outcome [1] 326048 0
Hypothermia (body temperature <36.0 Celsius as assessed by a digital thermometer) requiring escalation of care to invasive measures including placement in an isolette or radiant warmer, during initial admission to hospital after birth.
Timepoint [1] 326048 0
First hospital admission after birth (typically less than 7 days)
Secondary outcome [1] 389970 0
Days (post birth) to gain birth weight (as measured on standard postnatal ward weighing scales)
Timepoint [1] 389970 0
Any time during first hospital admission after birth
Secondary outcome [2] 389971 0
Weight at discharge from hospital (as measured by digital weighing scales in hospital)
Timepoint [2] 389971 0
Discharge from hospital - generally few days after birth (typically less than 7 days)
Secondary outcome [3] 389972 0
Weight at 28 days after birth (parent verbal record based on maternal child health assessments)
Timepoint [3] 389972 0
28 days after birth
Secondary outcome [4] 389973 0
Exclusive breast feeding at discharge (parent verbal statement)
Timepoint [4] 389973 0
Discharge from hospital
Secondary outcome [5] 389974 0
Exclusive breast feeding at 28 days of life (parent verbal statement)
Timepoint [5] 389974 0
28 days after birth
Secondary outcome [6] 389975 0
Any Antibiotic use (based on patient medical records)
Timepoint [6] 389975 0
Any time during first hospital admission after birth
Secondary outcome [7] 389976 0
Any Intravenous fluid use (based on patient medical records)
Timepoint [7] 389976 0
Any time during first hospital admission after birth
Secondary outcome [8] 389977 0
Nasogastric feed requirement (based on patient medical records)
Timepoint [8] 389977 0
Any time during first hospital admission after birth
Secondary outcome [9] 389978 0
Hypoglycaemia (defined as BSL <2.6 mmol/L) requiring admission to Special Care Nursery (based on patient medical records)
Timepoint [9] 389978 0
Any time during first hospital admission after birth
Secondary outcome [10] 389979 0
Jaundice requiring phototherapy (based on patient medical records)
Timepoint [10] 389979 0
Any time during first hospital admission after birth
Secondary outcome [11] 389980 0
Length of hospital stay (based on patient medical records)
Timepoint [11] 389980 0
Discharge from hospital
Secondary outcome [12] 389981 0
Readmission to hospital after initial discharge (based on patient medical records)
Timepoint [12] 389981 0
28 days after birth
Secondary outcome [13] 389982 0
All cause mortality
Timepoint [13] 389982 0
28 days after birth
Secondary outcome [14] 389983 0
Satisfaction score of using watch (based on study-specific questionnaire)
Timepoint [14] 389983 0
28 days after birth

Eligibility
Key inclusion criteria
Neonates born at Monash Medical Centre, Clayton who are of low birth weight (i.e. <2500 grams at birth) or small for gestational age (i.e. birth weight <10th centile) AND are being looked after by the mother/ parents in the postnatal ward
Minimum age
0 Days
Maximum age
1 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants who are born earlier than 35 weeks completed gestation, or who continue to stay in SCN beyond 24 hours of life for any reason will be excluded from the study

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes (Opaque sealed envelopes)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random sequence in blocks of 12,
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
Interim analysis is planned after 60 babies to confirm feasibility (i.e. acceptable study design/ sample size based on rates of incidence of primary outcome - hypothermia needing escalation of care).

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Feasibility not attained for primary outcome as pre planned
Date of first participant enrolment
Anticipated
1/03/2021
Actual
1/03/2021
Date of last participant enrolment
Anticipated
Actual
20/08/2021
Date of last data collection
Anticipated
Actual
20/09/2021
Sample size
Target
240
Accrual to date
Final
75
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18239 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 32303 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 307457 0
Self funded/Unfunded
Name [1] 307457 0
Dr Atul Malhotra
Country [1] 307457 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
246 Clayton Rd
Clayton
VIC 3168
Country
Australia
Secondary sponsor category [1] 308131 0
None
Name [1] 308131 0
Nil
Address [1] 308131 0
Nil
Country [1] 308131 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307535 0
Monash Health HREC
Ethics committee address [1] 307535 0
Ethics committee country [1] 307535 0
Australia
Date submitted for ethics approval [1] 307535 0
12/11/2020
Approval date [1] 307535 0
10/02/2021
Ethics approval number [1] 307535 0

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

Contacts
Principal investigator
Name 107582 0
Dr Atul Malhotra
Address 107582 0
Monash Children's Hospital
246 Clayton Rd
Clayton VIC 3168
Country 107582 0
Australia
Phone 107582 0
+61 3 85723650
Fax 107582 0
Email 107582 0
[email protected]
Contact person for public queries
Name 107583 0
Atul Malhotra
Address 107583 0
Monash Children's Hospital
246 Clayton Rd
Clayton VIC 3168
Country 107583 0
Australia
Phone 107583 0
+61 3 85723650
Fax 107583 0
Email 107583 0
[email protected]
Contact person for scientific queries
Name 107584 0
Atul Malhotra
Address 107584 0
Monash Children's Hospital
246 Clayton Rd
Clayton VIC 3168
Country 107584 0
Australia
Phone 107584 0
+61 3 8572 3650
Fax 107584 0
Email 107584 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified study data (all data collected)
When will data be available (start and end dates)?
At end of study (no end date)
Available to whom?
On reasonable request to relevant researchers
Available for what types of analyses?
Systematic review, meta-analysis, Individual patient data analysis
How or where can data be obtained?
By contact study principal investigator, Dr Atul Malhotra ([email protected])


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
SourceTitleYear of PublicationDOI
Dimensions AIDecreasing Hypothermia-Related Escalation of Care in Newborn Infants Using the BEMPU TempWatch: A Randomised Controlled Trial2021https://doi.org/10.3390/children8111068
N.B. These documents automatically identified may not have been verified by the study sponsor.