Evaluation of a Novel Neonatal Temperature Monitor

NCT03866122 | Unknown

• 1 other identifier: NTM-COMREC
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Neonatal Hypothermia

Outcome Measures

Primary Outcomes (1)

• Temperature measurement accuracy

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

  <72 hours

Study Arms (1)

Neonatal Temperature Monitor

EXPERIMENTAL

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.

Device: NTM Monitoring

Interventions

NTM Monitoring DEVICE

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.

Neonatal Temperature Monitor

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• William Marsh Rice University: lead
• Kamuzu University of Health Sciences: collaborator

Study Sites (1)

Rice University

Houston, Texas, 77030, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 32426530 DERIVED

Study Officials

• Rebecca Richards-Kortum, PhD

  William Marsh Rice University

  PRINCIPAL INVESTIGATOR

• Queen Dube, MD

  Kamuzu University of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Elias, MPH

CONTACT

713-348-6574; rebecca.elias@rice.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One or more neonatal temperature monitors will be applied to the same infant; results between the monitors will be compared.

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: March 7, 2019
• Study Start: September 6, 2017
• Primary Completion: September 6, 2022
• Study Completion: September 6, 2022
• Last Updated: September 10, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)