Specialty: Children, Primary sub-specialty: Neonatal
Conditions
Interventions
This is a feasibility and pilot study with qualitative interviews.
This is a single-centre clinical investigation of a medical device trial. Following informed consent, participants will be enrolled
Sponsors
University Hospitals Bristol and Weston NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Clic EEG: 1. Infants with gestational age >= 25 weeks undergoing aEEG monitoring using standard CFM for clinical reasons, or 2. Healthy term or near-term born infants with gestational age >= 36 weeks being cared for in the delivery suite or postnatal ward Qualitative interviews 1. Parents of infants enrolled in the study 2. Staff member (midwife or neonatal staff) looking after infants enrolled in the study
Exclusion criteria
Exclusion criteria: 1. Infants who have significant scalp swelling (e.g. subgaleal haemorrhage) or scalp injury (e.g. cuts or breaks in the skin). 2. known skin allergies to adhesives 3. open wounds, skin infections, burns or any other skin conditions at the application sites 4. Infants taking part in other research studies where it is felt that taking part in more than one study could affect the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Noisy signal quantification is measured by review and comparison of EEG and aEEG signal quality from Clic EEG and CFM, with determination based on impedance greater than 10 kilohms and proportion of recordings with high impedance quantified at one time point 2. Qualitative scoring of aEEG trace is measured by scoring 30 to 60 minutes of comparable time-locked noise-free segments from Clic EEG and CFM based on voltage and pattern criteria at one time point 3. Quantitative scoring of aEEG signals is measured by automated algorithmic review using ‘brain state of the newborn’ (BSN) via BabaCloud9, providing objective score comparison between Clic EEG and CFM at one time point 4. Acceptability of the Clic EEG system is measured by online or in-person qualitative interviews with staff and parents to assess usability and impact of remote monitoring at one time point, up to 8 weeks after giving birth or looking after the participants | — |
Countries
England, United Kingdom
Outcome results
None listed