Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001114336
Ethics application status
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Approved
Date submitted
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28/07/2026
Date registered
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8/09/2026
Date last updated
Help: Date last updated
8/09/2026
Date data sharing statement initially provided
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8/09/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
Continuous monitoring using skin bioimpedance in newborn babies to assess skin safety and signal quality
Scientific title
Measurement of transcutaneous bioelectrical impedance in preterm infants: a prospective study of skin safety, tolerability and bioimpedance signal quality
Additional trial identifiers [1] 317996 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records
Nil

Health condition
Health condition(s) studied:
Peripheral intravenous catheter infiltration and extravasation injury in neonates 343035 0
Condition category
Condition code
Reproductive Health and Childbirth 339131 339131 0 0
Complications of newborn
Skin 339132 339132 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Vedette transcutaneous bioelectrical impedance monitoring

All participants will undergo non-invasive continuous transcutaneous bioelectrical impedance monitoring using the investigational Vedette® device. Up to four neonatal ECG-style adhesive electrodes will be applied to intact skin. Where clinically appropriate, two electrodes will be placed on the limb containing a clinically indicated peripheral intravenous cannula, and two electrodes may be placed on the contralateral limb as a within-participant reference.

There is no predefined gestational-age or weight threshold for use of the two-electrode configuration. Where the treating neonatologist and bedside nursing staff consider that four electrodes cannot be safely or practically accommodated because of infant size, skin condition, clinical circumstances or routine care requirements, monitoring may be limited to two electrodes on the cannulated limb. Infants who are critically ill or haemodynamically unstable at screening are excluded from enrolment. If an enrolled infant subsequently becomes clinically unstable, electrode number may be reduced or monitoring may be stopped at the discretion of the treating clinical team.

Vedette is a non-invasive bioimpedance measurement device and is not an electrotherapy device; it does not deliver therapeutic electrical stimulation. Bioimpedance is measured using a very low-current, low-amplitude sinusoidal excitation signal applied through the neonatal ECG-style surface electrodes across a predefined range of measurement frequencies. The resulting patient current is in the microampere-to-nanoampere range depending on tissue/electrode impedance. There is no therapeutic modulation or therapeutic pulse train.

Monitoring will occur for a minimum of 5 hours and up to 24 hours per day. Monitoring sessions may occur over multiple days, either consecutively or intermittently, for example once weekly. The protocol does not specify a fixed maximum number of monitoring days; total duration is determined by clinical feasibility, infant stability, skin condition and routine care requirements.

The device will be used for research data collection only. It will not provide diagnostic information to the treating team, generate clinical alerts, direct treatment, alter intravenous therapy or replace routine visual inspection of the cannula site. Electrode placement or monitoring may be modified or stopped at any time if considered necessary by the treating clinical team.
Intervention code [1] 334904 0
Early detection / Screening
Description of the comparator or control
No separate control group. Where clinically appropriate, the contralateral limb may be monitored as a within-participant reference; participants are not allocated to a separate comparator arm.

Skin safety findings will also be contextualised against published neonatal medical adhesive-related skin injury data. Relevant historical data include the prospective cohort reported by de Oliveira Marcatto et al., involving premature neonates aged 28 to <37 weeks gestation with data collected from March to August 2019, and Barak et al., which specifically evaluated skin damage associated with adhesive ECG monitoring electrodes in low-birth-weight infants.

The 5% historical rate used in the study statistical framework is a conservative safety benchmark informed by published literature and local NICU clinical experience rather than an incidence estimate derived from a single historical cohort.

References:
de Oliveira Marcatto J, Santos AS, Oliveira AJF, Costa ACL, Regne GRS, da Trindade RE, et al. Medical adhesive-related skin injuries in the neonatology department of a teaching hospital. Nurs Crit Care. 2022;27(4):583–588. doi:10.1111/nicc.12621.
Barak M, Hershkowitz S, Rod R, Dror S. The use of a synthetic skin covering as a protective layer in the daily care of low birth weight infants. Eur J Pediatr. 1989;148:665–666. doi:10.1007/BF00441529.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 346370 0
Incidence of medical adhesive-related skin injury (MARSI) associated with Vedette monitoring electrodes
Timepoint [1] 346370 0
Skin will be assessed at baseline before electrode application, immediately after electrode removal, and 30 minutes after electrode removal. If redness or skin damage persists at the 30-minute assessment, an additional assessment will be performed at the next routine care period or approximately 24 hours after electrode removal to document recovery.
Primary outcome [2] 346371 0
Proportion of participants with at least one successful transcutaneous bioelectrical impedance recording
Timepoint [2] 346371 0
Continuously during each monitoring session of 5 to 24 hours, with the participant-level outcome assessed after completion of that participant’s monitoring period.
Primary outcome [3] 346519 0
Change in skin integrity at Vedette electrode sites, assessed using the Neonatal Skin Condition Score (NSCS)
Timepoint [3] 346519 0
At baseline before electrode application, immediately after electrode removal, and 30 minutes after electrode removal. Where clinically indicated following a persistent skin finding, an additional assessment may be performed at the next routine care period or approximately 24 hours after electrode removal.
Secondary outcome [1] 465544 0
Occurrence of peripheral intravenous catheter infiltration and/or extravasation during Vedette monitoring. This will be assessed as a composite secondary outcome.
Timepoint [1] 465544 0
Throughout each Vedette monitoring session, with any clinically identified infiltration and/or extravasation event recorded during the participant’s study involvement.
Secondary outcome [2] 465545 0
Time required to complete Vedette study setup, comprising electrode placement and device setup. This will be assessed as a composite setup-time outcome.
Timepoint [2] 465545 0
At the commencement of each Vedette monitoring session.
Secondary outcome [3] 465546 0
Acceptability and usability of Vedette monitoring in the neonatal intensive care unit
Timepoint [3] 465546 0
At the end of the participant’s data collection period.
Secondary outcome [4] 467283 0
Occurrence of interruptions to routine clinical care attributable to Vedette setup or monitoring.
Timepoint [4] 467283 0
Throughout each monitoring session and assessed at session completion.
Secondary outcome [5] 467284 0
Frequency of Vedette electrode repositioning or reapplication.
Timepoint [5] 467284 0
Throughout each monitoring session and assessed at session completion.
Secondary outcome [6] 467285 0
Occurrence of premature cessation of a planned Vedette monitoring session.
Timepoint [6] 467285 0
During each monitoring session and assessed at session completion.
Secondary outcome [7] 467286 0
Frequency of Vedette device restarts or troubleshooting events during monitoring.
Timepoint [7] 467286 0
Throughout each monitoring session and assessed at session completion.

Eligibility
Key inclusion criteria
Infants admitted to a participating neonatal intensive care unit who were born at a gestational age of 28 weeks 0 days or later, are more than 7 days old, and have a clinically indicated, in-situ peripheral intravenous cannula inserted as part of routine clinical care. Written informed consent must be provided by a parent or legal guardian. No intravenous cannula will be inserted solely for this study.
Minimum age
8 Days
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Critical illness or haemodynamic instability, as determined by the attending neonatologist.
A skin condition or compromised skin integrity at the proposed electrode sites that contraindicates safe application of the study electrodes.

Study design
Purpose of the study
Diagnosis
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
This is a safety-focused feasibility study. A one-sided one-sample non-inferiority analysis will be used to compare the proportion of participants experiencing medical adhesive-related skin injury or other electrode-associated skin injury with a historical baseline incidence of 5%. An absolute non-inferiority margin of 10 percentage points will be used, with a one-sided alpha of 0.025 and 80% power. Approximately 38 evaluable participants are required. Allowing for approximately 30% attrition or incomplete primary-outcome data, the planned enrolment is 55 neonates.

Skin-safety outcomes will be summarised as proportions with confidence intervals. The proportion of participants providing at least one successful transcutaneous bioelectrical impedance recording, defined as at least 5 continuous hours of recording meeting predefined artefact and signal-to-noise criteria, will be calculated and compared with the prespecified feasibility target. Exploratory associations between bioimpedance signals and clinical events, together with usability and practical-feasibility outcomes, will be analysed descriptively. The primary analysis will use the per-protocol population, with the full analysis set used for sensitivity analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/10/2026
Actual
Date of last participant enrolment
Anticipated
7/04/2028
Actual
Date of last data collection
Anticipated
7/04/2028
Actual
Sample size
Target
55
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 322545 0
Commercial sector/Industry
Name [1] 322545 0
Pretect Devices Pty Ltd
Country [1] 322545 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Pretect Devices Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 325506 0
None
Name [1] 325506 0
Address [1] 325506 0
Country [1] 325506 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321026 0
WA Health Central HREC
Ethics committee address [1] 321026 0
Ethics committee country [1] 321026 0
Australia
Date submitted for ethics approval [1] 321026 0
16/10/2025
Approval date [1] 321026 0
15/04/2026
Ethics approval number [1] 321026 0
RGS0000007800

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

Contacts
Principal investigator
Name 152414 0
Dr Samuel Bolland
Address 152414 0
Pretect Devices Pty Ltd, CERI, Level 1, 22 Stirling Highway, Nedlands WA 6009
Country 152414 0
Australia
Phone 152414 0
+61422257004
Fax 152414 0
Email 152414 0
[email protected]
Contact person for public queries
Name 152415 0
Samuel Bolland
Address 152415 0
Pretect Devices Pty Ltd, CERI, Level 1, 22 Stirling Highway, Nedlands WA 6009
Country 152415 0
Australia
Phone 152415 0
+61422257004
Fax 152415 0
Email 152415 0
[email protected]
Contact person for scientific queries
Name 152416 0
Samuel Bolland
Address 152416 0
Pretect Devices Pty Ltd, CERI, Level 1, 22 Stirling Highway, Nedlands WA 6009
Country 152416 0
Australia
Phone 152416 0
+61422257004
Fax 152416 0
Email 152416 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Individual participant data will not be made publicly available because the study involves a small and vulnerable neonatal population and includes investigational-device research data. Study findings will be reported in de-identified aggregate form.



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.