Evaluation of a Novel Neonatal Temperature Monitor
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/9/2019 |
| Start Date: | September 6, 2017 |
| End Date: | September 6, 2019 |
| Contact: | Paty Figueroa |
| Email: | paty.figueroa@rice.edu |
| Phone: | 7133484963 |
Evaluating the Accuracy of a Neonatal Temperature Monitor in Comparison With Existing Temperature Monitors
A team of researchers at Rice University and Queen Elizabeth Central Hospital (QECH) are
working to develop a low-cost temperature sensor that can continuously monitor an infant's
temperature (NTM). This robust, low-cost device will allow for the individualized monitoring
of each infant with alerts for hypo and hyperthermia. A reusable band placed around the
infant's abdomen to hold the temperature sensor will eliminate disposable components. This
study will assess the accuracy of this novel device against a gold standard (Philips
Intellivue patient monitor) and up to two existing devices (Bempu and Thermospot).
working to develop a low-cost temperature sensor that can continuously monitor an infant's
temperature (NTM). This robust, low-cost device will allow for the individualized monitoring
of each infant with alerts for hypo and hyperthermia. A reusable band placed around the
infant's abdomen to hold the temperature sensor will eliminate disposable components. This
study will assess the accuracy of this novel device against a gold standard (Philips
Intellivue patient monitor) and up to two existing devices (Bempu and Thermospot).
This study will assess the accuracy of this novel device against a commercially available
patient monitor (Philips Intellivue MP30). Results will be compared to that of two existing
devices designed for low resource settings: Bempu, a temperature monitor placed around an
infant's wrist; and Thermospot, a sticker that changes color with temperature.
This study will enroll up to 70 infants at Queen Elizabeth Central Hospital. Up to 35
subjects will be collected from the neonatal ward and 35 subjects from the Kangaroo Mother
Care (KMC) ward. This sample size will ensure that the investigators are able to collect
sufficient data from infants with a range of gestational ages, weights, temperatures, and
treatment locations (ie open cot, radiant warmer). The data from this study can be used to
calculate the sample size needed in a larger study to evaluate changes in outcomes and nurse
behavior related to the different temperature monitors (NTM, Bempu, Thermospot).
During the trial, the following steps will be taken:
A trained study nurse will assess the subject for clinical complications before attaching the
temperature monitoring devices.
1. A trained study nurse or clinician will attach the test temperature monitoring devices
to the infant. A trained research assistant from Rice University or from the Biomedical
Engineering Department at Malawi Polytechnic will observe all procedures and will notify
the nurse of any observed errors so they may be corrected. They will also be able to
answer any technical questions from the nurse. If there is any concern for the comfort
or skin of the infant, only one device may be placed on at a time (NTM, Bempu,
ThermoSpot).
2. The trained study nurse will attach the temperature probe from the commercial gold
standard as well as provide any other care needed.
3. A research assistant will use a laptop to collect data from the continuous temperature
monitors (NTM and gold standard). The nurse will record the temperature readings every
hour from all monitors on paper forms along with the standard of care.
4. Each time an alarm sounds from any device (Bempu and the commercial gold standard have
audible alarms), the nurse will record all temperature values including a reading taken
with the standard of care method. If the subject is found to be hyper/hypothermic, the
nurse will respond with the appropriate standard of care.
5. Temperature monitoring will continue for up to 3 days. The research assistant may ask
the nurse to remove and reapply the temperature probes during this period.
The goal of this study is to confirm the accuracy of these temperature monitors. Target
accuracy for NTM device is +/- 0.5 C. In order to confirm this temperature accuracy in the
settings of both the neonatal ward and the KMC ward, 35 subjects are needed in each setting.
The international standards for clinical thermometers, standard number 80601-2-56, requires
that 35 subjects from each patient population be tested to demonstrate the clinical accuracy
of the thermometer. The clinical accuracy is reported using a measure of bias as well as the
limits of agreement.
patient monitor (Philips Intellivue MP30). Results will be compared to that of two existing
devices designed for low resource settings: Bempu, a temperature monitor placed around an
infant's wrist; and Thermospot, a sticker that changes color with temperature.
This study will enroll up to 70 infants at Queen Elizabeth Central Hospital. Up to 35
subjects will be collected from the neonatal ward and 35 subjects from the Kangaroo Mother
Care (KMC) ward. This sample size will ensure that the investigators are able to collect
sufficient data from infants with a range of gestational ages, weights, temperatures, and
treatment locations (ie open cot, radiant warmer). The data from this study can be used to
calculate the sample size needed in a larger study to evaluate changes in outcomes and nurse
behavior related to the different temperature monitors (NTM, Bempu, Thermospot).
During the trial, the following steps will be taken:
A trained study nurse will assess the subject for clinical complications before attaching the
temperature monitoring devices.
1. A trained study nurse or clinician will attach the test temperature monitoring devices
to the infant. A trained research assistant from Rice University or from the Biomedical
Engineering Department at Malawi Polytechnic will observe all procedures and will notify
the nurse of any observed errors so they may be corrected. They will also be able to
answer any technical questions from the nurse. If there is any concern for the comfort
or skin of the infant, only one device may be placed on at a time (NTM, Bempu,
ThermoSpot).
2. The trained study nurse will attach the temperature probe from the commercial gold
standard as well as provide any other care needed.
3. A research assistant will use a laptop to collect data from the continuous temperature
monitors (NTM and gold standard). The nurse will record the temperature readings every
hour from all monitors on paper forms along with the standard of care.
4. Each time an alarm sounds from any device (Bempu and the commercial gold standard have
audible alarms), the nurse will record all temperature values including a reading taken
with the standard of care method. If the subject is found to be hyper/hypothermic, the
nurse will respond with the appropriate standard of care.
5. Temperature monitoring will continue for up to 3 days. The research assistant may ask
the nurse to remove and reapply the temperature probes during this period.
The goal of this study is to confirm the accuracy of these temperature monitors. Target
accuracy for NTM device is +/- 0.5 C. In order to confirm this temperature accuracy in the
settings of both the neonatal ward and the KMC ward, 35 subjects are needed in each setting.
The international standards for clinical thermometers, standard number 80601-2-56, requires
that 35 subjects from each patient population be tested to demonstrate the clinical accuracy
of the thermometer. The clinical accuracy is reported using a measure of bias as well as the
limits of agreement.
Inclusion Criteria:
- The subject is currently being treated at QECH in the neonatal or KMC ward.
- Study devices are available for use.
- The subject's caregiver has provided informed consent for their child to participate.
Exclusion Criteria:
- At the clinician's discretion for any reason including, but not limited to:
- potential for skin irritation
- Cough
- other condition that may preclude use of the temperature belt
- concurrent treatments that may require increased patient care
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