Back to resultsThe Correlation Between Adenoid Hypertrophy and Body Temperature in Children Before and After Adenoidectomy
Primary Purpose
Otolaryngological Diseases
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Temperature measurements
Sponsored by
About this trial
This is an interventional diagnostic trial for Otolaryngological Diseases
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Temperature measurements
Arm Description
Outcomes
Primary Outcome Measures
Changes in temperature
Secondary Outcome Measures
Full Information
NCT ID
NCT02965183
First Posted
November 13, 2016
Last Updated
November 21, 2016
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02965183
Brief Title
The Correlation Between Adenoid Hypertrophy and Body Temperature in Children Before and After Adenoidectomy
Official Title
The Correlation Between Adenoid Hypertrophy and Body Temperature in Children Before and After Adenoidectomy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Examination of the correlation between adenoid hypertrophy and body temperature in candidate children for adenoidectomy after exercise
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otolaryngological Diseases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Temperature measurements
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Temperature measurements
Primary Outcome Measure Information:
Title
Changes in temperature
Time Frame
one week before the surgery and one week after the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
The Correlation Between Adenoid Hypertrophy and Body Temperature in Children Before and After Adenoidectomy
We'll reach out to this number within 24 hrs