Clinical trial NCT03541434: Bioclinical Profile of Adenotonsillar Hypertrophy in the Pediatric Population
Official title: Analysis of Clinical, Pathologic and Molecular Markers of Adenotonsillar Hypertrophic Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Enlargement of Tonsil or Adenoid
Keywords: obstructive sleep apnea
tonsillitis
middle ear effusion
pathophysiology
score
Lead sponsor: University of Patras
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 134
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children presenting to the clinics of a Pediatric hospital.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bioclinical profile of adenotonsillar hypertrophy
timeFrame: One year post surgical procedure
Secondary outcomes:
measure: Clinical markers of adenotonsillar hypertrophy
timeFrame: One year post surgical procedure
measure: Laboratory markers of adenotonsillar hypertrophy
timeFrame: One year post surgical procedure
measure: Tympanometric findings of middle ear disease resulting from adenotonsillar hypertrophy
timeFrame: One year post surgical procedure
measure: Wide-Band tympanometric findings of middle ear disease resulting from adenotonsillar hypertrophy
timeFrame: One year post surgical procedure
measure: Molecular determinants of adenotonsillar hypertrophy
timeFrame: One year post surgical procedure
Other outcomes:
Locations:
city: Patras
country: Greece
facility: Children Hospital of Patras "Karamandaneio"
state: Achaia
city: Rio
country: Greece
facility: Patras University Hospital
state: Achaia
Study officials:
affiliation: Associate Professor of Physiology
name: Georgios T Stathopoulos
role: PRINCIPAL_INVESTIGATOR
References:
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