NCT03541434

Bioclinical Profile of Adenotonsillar Hypertrophy in the Pediatric Population

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 134 (actual)
• Sponsor: University of Patras · Academic / Other
• Sex: All
• Age: 1 Year – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Enlargement of Tonsil or Adenoid

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Complete Blood Count	White blood cell subgroups count
DIAGNOSTIC_TEST	Tympanometry	Conventional and multifrequency tympanometry, documenting middle ear admittance and absorbance
PROCEDURE	Tonsillectomy and/or adenoidectomy	Excision of palatine and/or pharyngeal tonsils.

Timeline

• Start date: 2017-02-01
• Primary completion: 2017-12-20
• Completion: 2018-06-30
• First posted: 2018-05-30
• Last updated: 2019-04-16

Locations

2 sites across 1 country: Greece