Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04241263 |
| Other study ID # |
A095011 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2020 |
| Est. completion date |
July 31, 2021 |
Study information
| Verified date |
January 2021 |
| Source |
Cambridge University Hospitals NHS Foundation Trust |
| Contact |
Kathryn Beardsall, MRCP |
| Phone |
01223746791 |
| Email |
kb274[@]cam.ac.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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:
1. 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.
2. 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.
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:
1. Quantitative assessment of the accuracy of the new system in comparison with standard
clinical monitoring systems
2. 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.
