Preterm InfantNCT04241263
Neonatal Wireless Monitoring System for Intensive Care
A study testing Wireless vital sign monitoring - comparative and Wireless vital sign monitoring - usability in people with Preterm Infant and Infant, Newborn, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Preterm Infant, Infant, Newborn, Low; Birthweight, Extremely (999 Grams or Less)
- What is being tested?
- Wireless vital sign monitoring - comparative and Wireless vital sign monitoring - usability
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2020to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Babies being cared for on the NICU at Addenbrooke's Hospital (ii) Written, informed parental consent
Who cannot join
- Known to have an intolerance to silicone or silicone gel adhesives. (ii) Has a pacemaker, or other implanted electronic device
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0QQ
Kathryn Beardsall, kb274@medschl.cam.ac.uk
About this study
Official title: Feasibility Study of a Neonatal Wireless Transmission System (NeWTS)
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.
Read more
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.
Read the 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
- Babies being cared for on the NICU at Addenbrookes Hospital
- Written, informed parental consent Exclusion criteria
- Known to have an intolerance to silicone or silicone gel adhesives.
- Has a pacemaker or other implanted electronic device.
Planned procedures Participants will have the newly developed wireless sensors for ECG, pulse oximetry, and temperature attached adjacent to the current clinical, wired sensors. Once the application sites have been identified and prepared, the sensors will be placed on the baby by an appropriately trained individual. The wireless receiver will connect to a separate patient monitor to log the comparative data. This study monitor will be covered and silenced such that data will not be visible to the clinical team, and it will not be possible to confuse the study monitor from the 'clinical' monitor. The sensors will be in place for a period of up to 24 hours. After this period, the study sensors will be removed, and the site inspected by a member of the research team and scored using the standard tissue viability scoring system already in use on the unit. The sensors will be disposed of in keeping with the unit and Trust policy.
After the study intervention, a questionnaire will be given to the nurse caring for the baby to determine their views on the wireless system.
Data collection Data will be collected from both the study monitor and the 'clinical' monitor. The data are formed of two types: parameter data and waveform data. Parameter data has a two-second interval. The waveform data has a period of approximately 4ms.
Qualitative study arm
Study population Up to 10 participants will be recruited from the Addenbrooke's Hospital. This is in line with other studies with similar cohorts and balances the need to obtain a range of views and experiences, with the imposition on parents' time in such an environment.
Inclusion criteria
- BAPM level transitional care babies who do not clinically require vital sign monitoring.
- The baby has had vital sign monitoring at some point during their stay on the unit.
- Written, informed parental consent Exclusion criteria
- Known to have an intolerance to silicone or silicone gel adhesives.
- Has a pacemaker or other implanted electronic medical device.
Planned procedure Babies who are not indicated for vital sign monitoring will have the wireless monitoring system attached. Once the application sites have been identified and prepared, the sensors will be placed on the baby by an appropriately trained individual. The wireless receiver will connect to the study monitor to log the vital sign data, and all alarms will be silenced. The monitor will be covered and silenced such that it will not impact on clinical care.
The baby will be transferred from the cot/incubator to the parent for kangaroo care as per standard NICU procedure. The parent and baby will remain in contact for as long as the parent is comfortable, and the baby remains stable and in keeping with unit policy and procedures. The baby will then be transferred back to the cot, and monitoring will be removed.
Semi-structured interviews lasting approximately 30 minutes will then be conducted with, (i) the nurse, and (ii) the parent(s). These interviews will focus on previous experiences with vital sign monitoring systems, and their experience of using the new wireless system.
- Being tested
- Wireless vital sign monitoring - comparative, Wireless vital sign monitoring - usability
- Keywords
- Patient monitoring, Medical device, Wireless
- Medical subject headings
- Premature Birth, Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wireless vital sign monitoring - comparativeDevice
Participants who currently have vital sign monitoring will, in addition, have the wireless system attached. We will then collect up to 24 hours of vital sign data from both systems, which will allow us to make direct comparisons between them.
Wireless vital sign monitoring - usabilityDevice
Babies will be recruited who do not currently require vital sign monitoring. The wireless system will be attached to these babies by nurses who have been trained in its use. A parent will then be asked to perform Kangaroo Care for as long as they feel comfortable. After the baby is placed back in its cot, and the sensors have been removed, we will conduct (separate) interviews with the nurse and the parent on the neonatal intensive care unit (NICU).
| Study group | Role | What they receive |
|---|---|---|
| Comparative assessment of data quality | Other | Quantitative comparison between the current wired system and the new wireless system Receives: Device: Wireless vital sign monitoring - comparative |
| Usability | Other | Qualitative assessment of the new wireless system Receives: Device: Wireless vital sign monitoring - usability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean (SD) difference in ECG waveform data
comparison of data between wired (standard care) and wireless system
Measured: Up to 24 hours of monitoring data per participant
Secondary outcomes (2)
Impact on care: qualitative interviews with parents and staff
Qualitative interviews
Measured: immediately post intervention
Impact on care: qualitative questionnaire with parents and staff
Questionnaire
Measured: immediately post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Mar 2020
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge
- Responsible party
- Principal investigator, Kathryn Beardsall, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- kathryn beardsall, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241263
- Sponsor's protocol ID
- A095011
- Status last verified
- Jan 2021
- First submitted
- 12 Jan 2020
- Last updated
- 12 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of a Neonatal Wireless Transmission System (NeWTS)
- ClinicalTrials.gov ID
- NCT04241263
- Acronym / sponsor ID
- A095011
- Keywords
- Patient monitoring, Medical device, Wireless
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Cambridge
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Babies being cared for on the NICU at Addenbrookes Hospital
- Written, informed parental consent Exclusion criteria
- Known to have an intolerance to silicone or silicone gel adhesives.
- Has a pacemaker or other implanted electronic device.
Planned procedures Participants will have the newly developed wireless sensors for ECG, pulse oximetry, and temperature attached adjacent to the current clinical, wired sensors. Once the application sites have been identified and prepared, the sensors will be placed on the baby by an appropriately trained individual. The wireless receiver will connect to a separate patient monitor to log the comparative data. This study monitor will be covered and silenced such that data will not be visible to the clinical team, and it will not be possible to confuse the study monitor from the 'clinical' monitor. The sensors will be in place for a period of up to 24 hours. After this period, the study sensors will be removed, and the site inspected by a member of the research team and scored using the standard tissue viability scoring system already in use on the unit. The sensors will be disposed of in keeping with the unit and Trust policy.
After the study intervention, a questionnaire will be given to the nurse caring for the baby to determine their views on the wireless system.
Data collection Data will be collected from both the study monitor and the 'clinical' monitor. The data are formed of two types: parameter data and waveform data. Parameter data has a two-second interval. The waveform data has a period of approximately 4ms.
Qualitative study arm
Study population Up to 10 participants will be recruited from the Addenbrooke's Hospital. This is in line with other studies with similar cohorts and balances the need to obtain a range of views and experiences, with the imposition on parents' time in such an environment.
Inclusion criteria
- BAPM level transitional care babies who do not clinically require vital sign monitoring.
- The baby has had vital sign monitoring at some point during their stay on the unit.
- Written, informed parental consent Exclusion criteria
- Known to have an intolerance to silicone or silicone gel adhesives.
- Has a pacemaker or other implanted electronic medical device.
Planned procedure Babies who are not indicated for vital sign monitoring will have the wireless monitoring system attached. Once the application sites have been identified and prepared, the sensors will be placed on the baby by an appropriately trained individual. The wireless receiver will connect to the study monitor to log the vital sign data, and all alarms will be silenced. The monitor will be covered and silenced such that it will not impact on clinical care.
The baby will be transferred from the cot/incubator to the parent for kangaroo care as per standard NICU procedure. The parent and baby will remain in contact for as long as the parent is comfortable, and the baby remains stable and in keeping with unit policy and procedures. The baby will then be transferred back to the cot, and monitoring will be removed.
Semi-structured interviews lasting approximately 30 minutes will then be conducted with, (i) the nurse, and (ii) the parent(s). These interviews will focus on previous experiences with vital sign monitoring systems, and their experience of using the new wireless system.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparative assessment of data quality | Other | Device: Wireless vital sign monitoring - comparativeQuantitative comparison between the current wired system and the new wireless system |
| Usability | Other | Device: Wireless vital sign monitoring - usabilityQualitative assessment of the new wireless system |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Babies being cared for on the NICU at Addenbrooke's Hospital (ii) Written, informed parental consent
Key exclusion criteria (1 listed)
- Known to have an intolerance to silicone or silicone gel adhesives. (ii) Has a pacemaker, or other implanted electronic device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wireless vital sign monitoring - comparativeParticipants who currently have vital sign monitoring will, in addition, have the wireless system attached. We will then collect up to 24 hours of vital sign data from both systems, which will allow us to make direct comparisons between them. | Device | Comparative assessment of data quality |
| Wireless vital sign monitoring - usabilityBabies will be recruited who do not currently require vital sign monitoring. The wireless system will be attached to these babies by nurses who have been trained in its use. A parent will then be asked to perform Kangaroo Care for as long as they feel comfortable. After the baby is placed back in its cot, and the sensors have been removed, we will conduct (separate) interviews with the nurse and the parent on the neonatal intensive care unit (NICU). | Device | Usability |
Primary outcome
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
2 secondary outcomes
Impact on care: qualitative interviews with parents and staff
Time frame: immediately post intervention
Impact on care: qualitative questionnaire with parents and staff
Time frame: immediately post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
kathryn beardsall principal investigator
University of Cambridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wireless vital sign monitoring - comparative and Wireless vital sign monitoring - usability in people with Preterm Infant and Infant, Newborn, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kathryn Beardsall, MRCP (01223746791, kb274@cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean (SD) difference in ECG waveform data (time frame: Up to 24 hours of monitoring data per participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2021.