Bioclinical Profile of Adenotonsillar Hypertrophy in the Pediatric Population

Study Overview
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Brief Summary
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Adenotonsillar hypertrophy is the principal cause of obstructive sleep apnea of childhood, yet little is known with regard to its pathophysiologic and molecular mechanisms. The present trial examines potential bioclinical markers of the disease.

Detailed Description
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Background: Tonsils and adenoids comprise the main bulk of Waldeyer's ring, which is commonly enlarged in childhood, until the age of 11. Obstructive sleep apnea caused by adenotonsillar hypertrophy is a major contributing factor to cardiorespiratory morbidity in the pediatric population. It is also responsible for otitis media with effusion, the most frequent cause of children's hearing loss. Even so, there is scarce knowledge of its molecular pathogenesis. Objective: Identification of clinical/molecular markers of adenotonsillar enlargement and investigation of their participation in the process of tissue hypertrophy. Methods: A prospective cohort of children with adenotonsillar hypertrophy were recruited starting on 02/01/2017 and ending on 12/22/2017. Demographic and clinical data including age, gender, sleep apnea severity, tonsillar size, presence of middle ear effusion, family history, review of systems as well as tympanometric and complete blood count results were recorded. Blood samples and tissue specimens from the therapeutic adenotonsillectomy procedure were archived for future analyses. Children with chronic tonsillitis and/or adenoiditis, who also underwent excision of tonsils and/or adenoids served as study controls. Informed consent was obtained from parents of all study participants.

Official Title
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Analysis of Clinical, Pathologic and Molecular Markers of Adenotonsillar Hypertrophic Disease

Conditions
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Enlargement of Tonsil or Adenoid

Intervention / Treatment
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* Diagnostic Test: Complete Blood Count
* Diagnostic Test: Tympanometry
* Procedure: Tonsillectomy and/or adenoidectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Available history and physical exam findings Available complete blood count and tympanometry at admission Exclusion Criteria: Previous tonsillectomy and/or adenoidectomy. Previous ear surgery. Acute infection during the past month. Active severe systemic disease.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy<br>Children with no history of adenotonsillar hypertrophy, recurrent tonsillitis, or middle ear effusion. They presented to the clinic for examination or a scheduled procedure. | Diagnostic Test: Complete Blood Count<br>* White blood cell subgroups count<br>Diagnostic Test: Tympanometry<br>* Conventional and multifrequency tympanometry, documenting middle ear admittance and absorbance<br>|
| Recurrent tonsillitis<br>Children with a history of recurret tonsillitis but no adenotonsillar hypertrophy. Diagnosis was based on physical exam and complete blood count. They presented to the clinic for a sceduled tonsillectomy. | Diagnostic Test: Complete Blood Count<br>* White blood cell subgroups count<br>Diagnostic Test: Tympanometry<br>* Conventional and multifrequency tympanometry, documenting middle ear admittance and absorbance<br>Procedure: Tonsillectomy and/or adenoidectomy<br>* Excision of palatine and/or pharyngeal tonsils.<br>|
| Middle ear effusion<br>Children with chronic middle ear effusion but no adenotonsillar hypertrophy. Diagnosis was based on physical exam and tympanometry. They presented to the clinic for scheduled myringotomy with or without adenoidectomy. | Diagnostic Test: Complete Blood Count<br>* White blood cell subgroups count<br>Diagnostic Test: Tympanometry<br>* Conventional and multifrequency tympanometry, documenting middle ear admittance and absorbance<br>Procedure: Tonsillectomy and/or adenoidectomy<br>* Excision of palatine and/or pharyngeal tonsils.<br>|
| Adenotonsillar hypertrophy<br>Children with tonsillar and/or adenoidal hypertrophy. Diagnosis was based on physical exam and partly on x-ray of nasopharynx or nasopharyngoscopy. They presented to the clinic for scheduled tonsillectomy and/or adenoidectomy. | Diagnostic Test: Complete Blood Count<br>* White blood cell subgroups count<br>Diagnostic Test: Tympanometry<br>* Conventional and multifrequency tympanometry, documenting middle ear admittance and absorbance<br>Procedure: Tonsillectomy and/or adenoidectomy<br>* Excision of palatine and/or pharyngeal tonsils.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioclinical profile of adenotonsillar hypertrophy | Clinical, laboratory, and molecular markers of adenotonsillar hypertrophy | One year post surgical procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical markers of adenotonsillar hypertrophy | Clinical findings from history (sympoms) and physical exam (signs) suggestive of adenotonsillar hypertrophy. | One year post surgical procedure | 
| Laboratory markers of adenotonsillar hypertrophy | Complete blood count (cells/L) | One year post surgical procedure | 
| Tympanometric findings of middle ear disease resulting from adenotonsillar hypertrophy | Middle ear pressure (dekaPascals) | One year post surgical procedure | 
| Wide-Band tympanometric findings of middle ear disease resulting from adenotonsillar hypertrophy | Resonance frequency of the middle ear (Hz) | One year post surgical procedure | 
| Molecular determinants of adenotonsillar hypertrophy | Immunohistochemical expression of molecular factors involved in tissue growth (semiquantitative scale) | One year post surgical procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obstructive sleep apnea, tonsillitis, middle ear effusion, pathophysiology, score