Complete blood count
Diagnostic TestWhite blood cell subgroups count
NCT Number: NCT03541434
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.
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Notify Me1 year–16 year
All sexes
Observational
Children Hospital of Patras "Karamandaneio", Pátrai, Achaia, Greece
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
White blood cell subgroups count
Conventional and multifrequency tympanometry, documenting middle ear admittance and absorbance
Excision of palatine and/or pharyngeal tonsils.
Time frame: One year post surgical procedure
Clinical, laboratory, and molecular markers of adenotonsillar hypertrophy
Time frame: One year post surgical procedure
Clinical findings from history (sympoms) and physical exam (signs) suggestive of adenotonsillar hypertrophy.
Time frame: One year post surgical procedure
Complete blood count (cells/L)
Time frame: One year post surgical procedure
Middle ear pressure (dekaPascals)
Time frame: One year post surgical procedure
Resonance frequency of the middle ear (Hz)
Time frame: One year post surgical procedure
Immunohistochemical expression of molecular factors involved in tissue growth (semiquantitative scale)
University of Patras
Other
Analysis of Clinical, Pathologic and Molecular Markers of Adenotonsillar Hypertrophic Disease
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