Otolaryngological DiseasesNCT02965183
The Correlation Between Adenoid Hypertrophy and Body Temperature in Children Before and After Adenoidectomy
A study testing Temperature measurements in people with Otolaryngological Diseases, run by Hillel Yaffe Medical Center.
Trial summary
Examination of the correlation between adenoid hypertrophy and body temperature in candidate children for adenoidectomy after exercise Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Otolaryngological Diseases
- What is being tested?
- Temperature measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy children with adenoid hypertrophy with or without OSA, SOM Parental concent. No other diseases
Who cannot join
- Syndromatic children Other diseases If getting antibiotics or other medications
About this study
Examination of the correlation between adenoid hypertrophy and body temperature in candidate children for adenoidectomy after exercise
Read the 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.
- Conditions
- Otolaryngological Diseases
- Being tested
- Temperature measurements
- Medical subject headings
- Otorhinolaryngologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temperature measurementsOther
| Study group | Role | What they receive |
|---|---|---|
| Temperature measurements | Experimental | Not described Receives: Other: Temperature measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in temperature
Measured: one week before the surgery and one week after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otolaryngological DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Itzhak Braverman, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965183
- Sponsor's protocol ID
- 0050-15
- Status last verified
- Nov 2016
- First submitted
- 13 Nov 2016
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between Adenoid Hypertrophy and Body Temperature in Children Before and After Adenoidectomy
- ClinicalTrials.gov ID
- NCT02965183
- Acronym / sponsor ID
- 0050-15
- Conditions
- Otolaryngological Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Dec 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 16 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temperature measurements | Experimental | Other: Temperature measurements |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy children with adenoid hypertrophy with or without OSA, SOM Parental concent. No other diseases
Key exclusion criteria (1 listed)
- Syndromatic children Other diseases If getting antibiotics or other medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temperature measurements | Other | Temperature measurements |
Primary outcome
Changes in temperature
Time frame: one week before the surgery and one week after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Temperature measurements in people with Otolaryngological Diseases, run by Hillel Yaffe Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in temperature (time frame: one week before the surgery and one week after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2016.