None listed
Conditions
Brief summary
Babies in neonatal intensive care often need peripheral intravenous (IV) lines, but fluid can leak from the vein into surrounding tissue and cause infiltration or extravasation injury. This study will assess whether the Vedette device can safely and continuously measure transcutaneous bioelectrical impedance near an IV site and collect signals of sufficient quality for future early-detection development. Up to 55 babies will have up to four neonatal ECG-style adhesive electrodes placed on the skin and connected to Vedette for 5 to 24 hours per day, without changing their usual treatment or replacing routine IV-site checks. The main outcomes are the frequency of electrode-related skin injury and the proportion of babies who provide at least one usable recording lasting five continuous hours. The study will also explore whether changes in the bioimpedance signal correspond with clinical events such as IV infiltration, swelling or IV-site changes.
Interventions
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-par
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.
Sponsors
Pretect Devices Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
8 Days to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed