Feasibility Study of a Neonatal Wireless Transmission System (NeWTS)
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Mean (SD) difference in ECG waveform data
Study Overview
Brief Summary
Babies who require intensive care need to have their heart rate, oxygen levels and temperature measured continuously using specially designed monitors. These monitors allow the clinical team to constantly assess the baby and see if they are becoming unwell. However, these monitors each have separate wires to connect them to the baby. Another important part of care in these babies is being able to allow parents to hold their babies, getting them out of their incubators to be cuddled. This is called Kangaroo care and has been shown to impact on long term health for both babies and parents.
We have designed a system to free babies of the wires that tether them to the monitors. This system has been tested in adults and we now want to test them on the babies.
There are two study parts with two different questions:
- How good is the data? This will compare the new wireless system with the existing system. Babies will have both standard wired monitors and the new wireless monitor on at the same time so we can compare the data to see how good is the quality of the data collected on the new system.
- What do parents and staff think about the wireless system during Kangaroo care? Babies who no longer need monitoring (but who previously had been monitored with the wired system), will have the wireless system attached and the parent will take their baby from the cot for Kangaroo Care. After the baby has been placed back in the cot, we will conduct interviews with the parent and the nurse to find out what they thought of the new system.
We hope this will help the investigators to understand about how good the data is we collect and how we might be able to improve the system.
Detailed Description
Summary of study design
This is a single-center study recruiting from the neonatal intensive care unit (NICU) at Addenbrooke's Hospital, Cambridge. There are 2 study parts:
- Quantitative assessment of the accuracy of the new system in comparison with standard clinical monitoring systems
- Qualitative Assessment of parent and staff views of caring for babies with the new system in comparison with conventional clinical monitoring systems
Quantitative study arm Study population Up to 24 participants will be recruited from the Addenbrooke's Hospital NICU. The participants will be recruited from three groups, defined by the BAPM Categories of Care The population size has been selected to include sufficient babies to collect a reasonable amount of data to ascertain, with confidence, our defined outcomes. Furthermore, the data should come from across the range of variables seen in babies requiring intensive care while limiting exposure of the infants at most risk. The study will be performed in a stepwise fashion, starting with those infants requiring lower dependency care.
Inclusion criteria
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Device Feasibility
- Masking
- None
Masking Description
This is a feasibility study but there are two arms and the babies, parents and staff will all be considered participants -it will be approximately 20 families recruited
Eligibility Criteria
- Ages
- — to 6 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •(i) Babies being cared for on the NICU at Addenbrooke's Hospital (ii) Written, informed parental consent
Exclusion Criteria
- •(i) Known to have an intolerance to silicone or silicone gel adhesives. (ii) Has a pacemaker, or other implanted electronic device
Arms & Interventions
Comparative assessment of data quality
Quantitative comparison between the current wired system and the new wireless system
Intervention: Wireless vital sign monitoring - comparative (Device)
Usability
Qualitative assessment of the new wireless system
Intervention: Wireless vital sign monitoring - usability (Device)
Outcomes
Primary Outcomes
Mean (SD) difference in ECG waveform data
Time Frame: Up to 24 hours of monitoring data per participant
comparison of data between wired (standard care) and wireless system
Secondary Outcomes
- Impact on care: qualitative interviews with parents and staff(immediately post intervention)
- Impact on care: qualitative questionnaire with parents and staff(immediately post intervention)
Investigators
Kathryn Beardsall
University Lecturer, Consultant Neonatologist
Cambridge University Hospitals NHS Foundation Trust