Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001049864
Ethics application status
Approved
Date submitted
21/05/2021
Date registered
10/08/2021
Date last updated
11/11/2022
Date data sharing statement initially provided
10/08/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Tablet-based documentation during neonatal resuscitation
Scientific title
Accuracy of documentation during neonatal resuscitation: comparison of an app-based, or paper-based tool versus a live video recording
Secondary ID [1] 304279 0
not applicable
Universal Trial Number (UTN)
Trial acronym
The TABLET study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
neonatal resuscitation 322006 0
Condition category
Condition code
Reproductive Health and Childbirth 319727 319727 0 0
Complications of newborn
Public Health 320295 320295 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In newborns requiring resuscitation in the delivery room a researcher will be randomised to use
1. An application (app)-based electronic documentation tool (NeoChart +) via tablet
Or
2. Paper based documentation form to document neonatal resuscitation interventions
For each arm in this study details to be collected using the app and paper based form include: any neonatal resuscitation interventions ( intermittent positive pressure ventilation, continuous positive pressure0 applied including duration, insertion of endotracheal tube, outcome and medications administered, administration of cardiac compressions, use of supplemental oxygen during the resuscitation.
We will also recorded demographic and perinatal data relating to the resuscitation event including mode of delivery vaginal vs. caesarean delivery, and gestational age.

Data will be recorded for the duration of observation, e.g. from delivery until successful resuscitation or at least 10 minutes after birth.
Intervention code [1] 321074 0
Other interventions
Comparator / control treatment
In newborns requiring resuscitation in the delivery room the gold standard for comparison will be a video-recording of the neonatal resuscitation interventions. A researcher is responsible for setting up the videorecording system. A researcher not present at the resuscitation will view the recording to accurately record events of interest. These will be used to compare events with tablet and paper documentation.
Control group
Active

Outcomes
Primary outcome [1] 327593 0
Precision and accuracy of time to face mask application assessed and documented by a researcher using tablet based documentation and a researcher using paper based documentation compared with video recording of resuscitation
Timepoint [1] 327593 0
During resuscitation
Primary outcome [2] 327879 0
Precision and accuracy of time to start and stop positive pressure ventilation assessed and documented by a researcher using tablet based documentation and a researcher using paper based documentation compared with video recording of resuscitation
Timepoint [2] 327879 0
During resuscitation
Primary outcome [3] 327880 0
Precision and accuracy of time to attempt endotracheal intubation assessed and documented by a researcher using tablet based documentation and a researcher using paper based documentation compared with video recording of resuscitation
Timepoint [3] 327880 0
During resuscitation
Secondary outcome [1] 395836 0
A composite outcome of documentation errors including time error, numerical error, commission, and omission error for SpO2 (%) (measured by pulse oximeter) recordings will be assessed by tablet based documentation OR paper based documentation by a researcher against video recording of resuscitation
Timepoint [1] 395836 0
3, 5 and 10 minutes after birth
Secondary outcome [2] 395837 0
A composite outcome of documentation errors including time error, numerical error, commission and omission, error for heart rate (bpm)(measured by pulse oximeter) recordings will be assessed by tablet based documentation OR paper based documentation by a researcher against video recording of resuscitation
Timepoint [2] 395837 0
3, 5 and 10 minutes after birth
Secondary outcome [3] 395838 0
A composite outcome of documentation errors including time error, numerical error,omission, and commission error for fraction of inspired oxygen (FIO2)(set on flow meter) recordings will be assessed by tablet based documentation OR paper based documentation by a researcher against video recording of resuscitation
Timepoint [3] 395838 0
3,5 and 10 minutes after birth
Secondary outcome [4] 397843 0
Primary outcome:Time to start/stop chest compressions if given during resuscitation. Measured timer in the digital record when using the tablet for documentation. The researcher using a paper based method of documentation will use the Apgar timer built into the radiant warmer. Time recorded in the tablet and paper documentation will be compared against video recording of resuscitation.
Timepoint [4] 397843 0
Primary outcome: At any time during resuscitation in the delivery room
Secondary outcome [5] 397844 0
Primary outcome: Time to first change in FiO2 from the initial FiO2 used in the resuscitation.
Measured using timer in the digital record when using the tablet for documentation. The researcher using a paper based method of documentation will use the Apgar timer built into the radiant warmer. Time recorded in the tablet and paper documentation will be compared against video recording of resuscitation.
Timepoint [5] 397844 0
Primary outcome: any time during resuscitation

Eligibility
Key inclusion criteria
All high-risk deliveries (code green sections, neonatal code blues, known fetal abnormalities needing support during transition, preterm infants <32 weeks’ gestation) during the study period and whom parents accept to participate.
Minimum age
0 Hours
Maximum age
1 Hours
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Refusal of staff to participate or subsequent refusal of parental consent.
Research staff unavailable.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
At each birth, a researcher is randomised to use the tablet OR paper for documentation during resuscitation using sequentially numbered sealed opaque envelopes.
Each envelope contains two small opaque envelopes, one small envelope has a card noting allocation to tablet, the other allocation to paper documentation.
At each birth one of the researchers opens the numbered envelope and chooses one of the smaller envelopes. The card within the smaller envelope reveals documentation allocation for that researcher. The second researcher is allocated the alternative method of documentation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The envelopes are prepared by an admin assistant not part of the research team.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
A researcher is randomised to the method of documentation, tablet or paper. The researchers have no involvement in clinical management of an infant.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
For each method and primary outcome, the difference in time interval from the gold standard (video) will be calculated. To compare methods, the difference in mean time differences, together with a 95% confidence interval, will be estimated. Where the differences are visually assessed as being skewed, the difference in median time differences, together with 95% CI will be estimated. The hypothesis of no difference between methods will be assessed using t test or Mann-Whitney test (for skewed data).
To compare error rates between methods, the difference in error rate, together with a 95% CI, will be estimated. The hypothesis of no difference between methods will be assessed using the chi-square test.
Stata® statistical software package 15.0 (SatatCorp, USA)will be used to perform the statistical analyses.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Restrictions on clinical research due to COVID19
Date of first participant enrolment
Anticipated
Actual
30/06/2021
Date of last participant enrolment
Anticipated
30/09/2021
Actual
24/08/2021
Date of last data collection
Anticipated
30/09/2021
Actual
24/08/2021
Sample size
Target
65
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19514 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 34110 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 308655 0
Hospital
Name [1] 308655 0
Newborn Research Centre at The Royal Women's Hospital
Country [1] 308655 0
Australia
Primary sponsor type
Hospital
Name
The Royal Women's Hospital
Address
The Royal Women's Hospital
20 Flemington Road
Parkville, Vic, 3052
Country
Australia
Secondary sponsor category [1] 309533 0
None
Name [1] 309533 0
Address [1] 309533 0
Country [1] 309533 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308581 0
The Royal Women's Hospital
Ethics committee address [1] 308581 0
Ethics committee country [1] 308581 0
Australia
Date submitted for ethics approval [1] 308581 0
17/05/2021
Approval date [1] 308581 0
01/07/2021
Ethics approval number [1] 308581 0
19/33

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

Contacts
Principal investigator
Name 111218 0
Dr Marta Thio
Address 111218 0
Newborn Research Centre
The Royal Women's Hospital
20 Flemington Road
Parkville, Vic, 3052
Country 111218 0
Australia
Phone 111218 0
+61 3 8345 3767
Fax 111218 0
Email 111218 0
Marta.ThioLluch@thewomens.org.au
Contact person for public queries
Name 111219 0
Marta Thio
Address 111219 0
Newborn Research Centre
The Royal Women's Hospital
20 Flemington Road
Parkville, Vic, 3052
Country 111219 0
Australia
Phone 111219 0
+61 3 8345 3767
Fax 111219 0
Email 111219 0
Marta.ThioLluch@thewomens.org.au
Contact person for scientific queries
Name 111220 0
Marta Thio
Address 111220 0
Newborn Research Centre
The Royal Women's Hospital
20 Flemington Road
Parkville, Vic, 3052
Country 111220 0
Australia
Phone 111220 0
+61 3 8345 3767
Fax 111220 0
Email 111220 0
Marta.ThioLluch@thewomens.org.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?
de-identified primary outcome data
When will data be available (start and end dates)?
After publication of trial results - no end date
Available to whom?
Researchers
Available for what types of analyses?
Meta-analysis
How or where can data be obtained?
Contact the primary investigator at Marta.ThioLluch@thewomens.org.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.