Recruiting

Neonatal Temperature Monitor

Sponsor:

William Marsh Rice University

Code:

NCT03866122

Conditions

Neonatal Hypothermia

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

NTM Monitoring

Study Details

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

Study ID

NCT03866122

Start date

Sep 6, 2017

Status verified date

Sep, 2021

Completion date

Sep 6, 2022

Anticipated

Primary completion date

Sep 6, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Neonatal Temperature Monitor

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.

Interventions

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.

Primary outcome measure

  • Temperature measurement accuracy [ Time Frame: <72 hours ]

Central Contacts and Locations

Central contacts

Rebecca Elias, MPH

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

Locations

Rice University

Recruiting

Houston, Texas, United States, 77030

Contacts

Rebecca R Richards-Kortum, PhD

713-348-3823rkortum@rice.edu

Z M Oden, PhD

7133484156moden@rice.edu

More Information

Sponsor

William Marsh Rice University

Last update posted

Sep 10, 2021

Last verified

Sep, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by William Marsh Rice University on 2021-09-10.