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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02965183
Other study ID # 0050-15
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 13, 2016
Last updated November 21, 2016
Start date December 2016
Est. completion date December 2018

Study information

Verified date November 2016
Source Hillel Yaffe Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

Examination of the correlation between adenoid hypertrophy and body temperature in candidate children for adenoidectomy after exercise


Description:

Examination of the correlation between adenoid hypertrophy and body temperature in candidate children for adenoidectomy after exercise.

Adenoid hypertrophy and adenoiditis are accompanied by chronic rhinitis with or without otitis media. It is very common phenomena at ages 2-6 years and those children are symptomatic with snoring, rhinitis, nasal obstruction.

In healthy children with nasal obstruction, body temperature can be elevated following exercise.

As adenoiditis and chronic rhinitis are accompanied by inflammatory process, we would like to examine body temperature of children with adenoid hypertrophy before after exercise.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 10 Years
Eligibility Inclusion Criteria:

- Healthy children with adenoid hypertrophy with or without OSA, SOM Parental concent. No other diseases

Exclusion Criteria:

- Syndromatic children Other diseases If getting antibiotics or other medications

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

Other:
Temperature measurements


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in temperature one week before the surgery and one week after the surgery No