Bioclinical Profile of Adenotonsillar Hypertrophy in the Pediatric Population

Completed

• Conditions: Enlargement of Tonsil or Adenoid

• Registration Number: NCT03541434
• Lead Sponsor: University of Patras

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.

Study Timeline

• Study Start: 2017-02-01
• Primary Completion: 2017-12-20
• Study First Submitted: 2018-05-09
• Study First Submitted QC: 2018-05-29
• Study First Posted: 2018-05-30
• Study Completion: 2018-06-30
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bioclinical profile of adenotonsillar hypertrophy	One year post surgical procedure	Clinical, laboratory, and molecular markers of adenotonsillar hypertrophy

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Children Hospital of Patras "Karamandaneio"; 🇬🇷 Patras, Achaia, Greece

Patras University Hospital; 🇬🇷 Rio, Achaia, Greece