Measure heart rate, blood oxygen levels and temperature in newborn babies Neonatal Diseases
Conditions
Interventions
This is an observational study. We will evaluate the VS Patch device on 50 newborn babies
this number has been selected to satisfy requirements stipulated by regulatory bodies. These babies will be recruited from two labour suites and two neonatal units. We will recruit babies ranging from
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Infants of 24 weeks gestation and above within the labour suite and anticipated to need vital sign monitoring 2. Infants of 24 weeks gestation and above within the neonatal unit deemed stable by the clinical team and undergoing vital sign monitoring 3. All infants must have verbal or written informed consent from the parent/carer 4. All infants must have a realistic prospect of survival as determined by the attending clinical team
Exclusion criteria
Exclusion criteria: 1. Infants that are not for active resuscitation 2. Infants that are receiving therapeutic hypothermia 3. Infants that are undergoing end-of-life care 4. Infants that have had surgery involving the chest/upper abdominal area 5. If multiple births, then only the first baby born shall be recruited (due to resource limitations with equipment and researchers attending the birth)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurement of heart rate and oxygen saturations by the VS patch compared with predicate devices in clinical use (ECG and pulse oximeter) during neonatal care | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Signal acquisition time (seconds) of VS Patch device for a) ECG and b) photoplysthmogram of optical signal from time of placement on baby 2. Comparison of surface temperature measurement of VS Patch (oC) compared to standard clinical measures taken by attending clinical team during first hour of patch in place | — |
Countries
England, United Kingdom
Contacts
Public ContactDon Sharkey
Outcome results
None listed