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Evaluation of a Novel Neonatal Temperature Monitor

NCT03866122 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-09-10

No results posted yet for this study

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).

Conditions

  • Neonatal Hypothermia

Interventions

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.

Sponsors & Collaborators

  • Kamuzu University of Health Sciences

    collaborator OTHER

  • William Marsh Rice University

    lead OTHER

Principal Investigators

  • Rebecca Richards-Kortum, PhD · William Marsh Rice University

  • Queen Dube, MD · Kamuzu University of Health Sciences

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-06
Primary Completion
2022-09-06
Completion
2022-09-06

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03866122 on ClinicalTrials.gov