Evaluation of a Novel Neonatal Temperature Monitor

Neonatal Hypothermia Clinical Trial

Official title:

Evaluating the Accuracy of a Neonatal Temperature Monitor in Comparison With Existing Temperature Monitors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03866122
• Other study ID #: NTM-COMREC
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2017
• Est. completion date: September 6, 2022

Study information

• Verified date: September 2021
• Source: William Marsh Rice University
• Contact: Rebecca Elias, MPH
• Phone: 713-348-6574
• Email: rebecca.elias[@]rice.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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 150 infants at Queen Elizabeth Central Hospital. Up to 75 subjects will be collected from the neonatal ward and 75 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, 75 subjects are needed in each setting. The international standards for clinical thermometers, standard number 80601-2-56, requires that 75 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 6, 2022
• Est. primary completion date: September 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Hypothermia
• Neonatal Hypothermia

Intervention

Device:
• NTM Monitoring
NTM and a patient monitor will continuously collect temperature for up to 72 hours. Additionally, Bempu and Thermospot may monitor temperature for up to 72 hours.

Locations

Country	Name	City	State
United States	Rice University	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
William Marsh Rice University	University of Malawi College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Temperature measurement accuracy	Continuously measured temperature for test devices compared against Philips Intellivue patient monitor	<72 hours