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Evaluation of a Novel Neonatal Temperature Monitor

Primary Purpose

Neonatal Hypothermia

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NTM Monitoring
Sponsored by
William Marsh Rice University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Neonatal Hypothermia

Eligibility Criteria

undefined - 28 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rice UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neonatal Temperature Monitor

Arm Description

One or more test devices (NTM, Bempu, Thermospot) will be attached to the infant in the neonatal intensive care unit (NICU) or KMC ward along with the Philips Intellivue patient monitor. Temperature will be monitored continuously using each device for up to 72 hours.

Outcomes

Primary Outcome Measures

Temperature measurement accuracy
Continuously measured temperature for test devices compared against Philips Intellivue patient monitor

Secondary Outcome Measures

Full Information

First Posted
January 3, 2019
Last Updated
September 1, 2021
Sponsor
William Marsh Rice University
Collaborators
Kamuzu University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03866122
Brief Title
Evaluation of a Novel Neonatal Temperature Monitor
Official Title
Evaluating the Accuracy of a Neonatal Temperature Monitor in Comparison With Existing Temperature Monitors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 6, 2017 (Actual)
Primary Completion Date
September 6, 2022 (Anticipated)
Study Completion Date
September 6, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
William Marsh Rice University
Collaborators
Kamuzu University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).
Detailed 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. 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). The trained study nurse will attach the temperature probe from the commercial gold standard as well as provide any other care needed. 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Hypothermia

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
One or more neonatal temperature monitors will be applied to the same infant; results between the monitors will be compared.
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neonatal Temperature Monitor
Arm Type
Experimental
Arm Description
One or more test devices (NTM, Bempu, Thermospot) will be attached to the infant in the neonatal intensive care unit (NICU) or KMC ward along with the Philips Intellivue patient monitor. Temperature will be monitored continuously using each device for up to 72 hours.
Intervention Type
Device
Intervention Name(s)
NTM Monitoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Temperature measurement accuracy
Description
Continuously measured temperature for test devices compared against Philips Intellivue patient monitor
Time Frame
<72 hours

10. Eligibility

Sex
All
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Elias, MPH
Phone
713-348-6574
Email
rebecca.elias@rice.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Richards-Kortum, PhD
Organizational Affiliation
William Marsh Rice University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Queen Dube, MD
Organizational Affiliation
Kamuzu University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rice University
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca R Richards-Kortum, PhD
Phone
713-348-3823
Email
rkortum@rice.edu
First Name & Middle Initial & Last Name & Degree
Z M Oden, PhD
Phone
7133484156
Email
moden@rice.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32426530
Citation
Sosa Saenz SE, Hardy MK, Heenan M, Oden ZM, Richards-Kortum R, Dube Q, Kawaza K. Evaluation of a continuous neonatal temperature monitor for low-resource settings: a device feasibility pilot study. BMJ Paediatr Open. 2020 May 7;4(1):e000655. doi: 10.1136/bmjpo-2020-000655. eCollection 2020.
Results Reference
derived

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Evaluation of a Novel Neonatal Temperature Monitor

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