Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT03147534
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 with tubes in their ear(s) cannot participate in the tympanic comparison, but this is not exclusionary for InstaTemp MD and definitive comparator (e.g. rectal or oral) measurements.
* 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
10 Years
Study:
NCT03147534
Study Brief:
Protocol Section:
NCT03147534