Comparison of Thermometry in Canada for Pediatrics

NCT03147534 | Withdrawn FDA Device

• 1 other identifier: CIT-CRCP-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

Compare and assess the accuracy and reliability of the InstaTemp MD® device to techniques presently in use for measuring temperature in infants and children in a Canadian clinical setting.

Conditions

Healthy; Febrile Illness

Outcome Measures

Primary Outcomes (1)

• Temperature measurements using "Welch Allyn" (oral/rectal), Covidien (tympanic) and ARC InstaTempMD (non-touch, infrared) in degrees Celcius and will be compared with three consecutive measurements with each thermometer.

  Compare the compendia thermometers in each age range to the InstaTemp MD to determine average clinical bias.

  Participant will only be required to attend one visit which will last up to a maximum of 30 minutes for the duration of the study.

Secondary Outcomes (1)

• Mean Comparison Analysis. Temperature measurements using "Welch Allyn" (oral/recta.), Covidien (tympanic) and ARC InstaTemp MD (non-touch, infrared) in degrees Celcius and will be compared with three consecutive measurements with each thermometer.

  Participant will only be required to attend one visit which will last up to a maximum of 30 minutes for the duration of the study.

Study Arms (3)

Children Age 1 month to 2 years

ACTIVE COMPARATOR

Collecting temperatures on patients using the ARC InstaTemp MD and a "Welch Allyn" rectal thermometer.

Device: InstaTemp MD; Device: "Welch Allyn", rectal

Children > 2 to 5 years

ACTIVE COMPARATOR

Collecting temperatures on patients using the ARC InstaTemp MD, the "Welch Allyn" rectal and Covidien tympanic thermometer.

Device: InstaTemp MD; Device: "Welch Allyn", rectal; Device: Covidien, tympanic

Children > 5 to ≤ 10 years

ACTIVE COMPARATOR

Collecting temperatures on patients using the ARC InstaTemp MD, the "Welch Allyn" oral and the Covidien tympanic thermometer.

Device: InstaTemp MD; Device: "Welch Allyn", oral; Device: Covidien, tympanic

Interventions

InstaTemp MD DEVICE

The InstaTemp MD is a hand held electronic infrared thermometer that is intended to accurately measure human body temperature without contact with the human body.

Children > 2 to 5 years; Children > 5 to ≤ 10 years; Children Age 1 month to 2 years

"Welch Allyn", rectal DEVICE

The "Welch Allyn" rectal thermometer is intended to measure human body temperature.

Children > 2 to 5 years; Children Age 1 month to 2 years

"Welch Allyn", oral DEVICE

The "Welch Allyn" oral thermometer is intended to measure human body temperature.

Children > 5 to ≤ 10 years

Covidien, tympanic DEVICE

The Covidien tympanic thermometer is intended to measure human body temperature.

Children > 2 to 5 years; Children > 5 to ≤ 10 years

Eligibility Criteria

• Age: 1 Month - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children Age 1 month to ≤ 10 years old
• Male or female
• Subject's parent or legal guardian over the age of 18 years must sign an informed consent form before any study-related procedures are performed
• Subjects who in the opinion of the investigator (or as required by the ethics committee) have the capacity to understand and sign an assent form, must provide written assent

You may not qualify if:

• Subjects who in the opinion of the researcher are too agitated, distressed or who are otherwise unable to cooperate with study procedures
• Subjects whose forehead cannot be fully exposed to the ambient condidtions for at least 15 minutes.
• Subjects with signs or recent history of inflammation or infection of the forehead or at the reference clinical test site.
• Subjects currently using cooling blankets or fans
• Subjects currently receiving treatment with thyroxine, barbiturates, antipsychotics, cortico-steroids (oral iv, or topically applied to forehead)
• Subjects currently alcohol intoxicated
• Subjects with documented illicit durg use in the previous 5 days
• Subjects that have had any hot or cold drinks within 15 minutes prior to a sublingual reading
• Subject is taking any medication that in the opinion of the investigator may alter the temperature of the child
• Subjects participating in a clinical trial of an investigational medicinal product within the last 30 days.

Sponsors & Collaborators

• ARC Devices: lead

Study Sites (2)

Center for Pediatric Excellence

Ottawa, Ontario, K2G1W2, Canada

Location

Agoo Children's Health and Wellness Centre

Laval, Quebec, H7P 0H9, Canada

Location

MeSH Terms

Interventions

Administration, Rectal

Intervention Hierarchy (Ancestors)

Administration, Mucosal; Administration, Topical; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Judy van Stralen, MD FRCPC

  Center for Pediatric Excellence

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: May 10, 2017
• Study Start: February 1, 2017
• Primary Completion: May 8, 2018
• Study Completion: May 8, 2018
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)