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Bioclinical Profile of Adenotonsillar Hypertrophy in the Pediatric Population

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03541434
Enrollment
134
Registered
2018-05-30
Start date
2017-02-01
Completion date
2018-06-30
Last updated
2019-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enlargement of Tonsil or Adenoid

Keywords

obstructive sleep apnea, tonsillitis, middle ear effusion, pathophysiology, score

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.

Interventions

DIAGNOSTIC_TESTComplete Blood Count

White blood cell subgroups count

DIAGNOSTIC_TESTTympanometry

Conventional and multifrequency tympanometry, documenting middle ear admittance and absorbance

PROCEDURETonsillectomy and/or adenoidectomy

Excision of palatine and/or pharyngeal tonsils.

Sponsors

University of Patras
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 16 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Bioclinical profile of adenotonsillar hypertrophyOne year post surgical procedureClinical, laboratory, and molecular markers of adenotonsillar hypertrophy

Secondary

MeasureTime frameDescription
Clinical markers of adenotonsillar hypertrophyOne year post surgical procedureClinical findings from history (sympoms) and physical exam (signs) suggestive of adenotonsillar hypertrophy.
Laboratory markers of adenotonsillar hypertrophyOne year post surgical procedureComplete blood count (cells/L)
Tympanometric findings of middle ear disease resulting from adenotonsillar hypertrophyOne year post surgical procedureMiddle ear pressure (dekaPascals)
Wide-Band tympanometric findings of middle ear disease resulting from adenotonsillar hypertrophyOne year post surgical procedureResonance frequency of the middle ear (Hz)
Molecular determinants of adenotonsillar hypertrophyOne year post surgical procedureImmunohistochemical expression of molecular factors involved in tissue growth (semiquantitative scale)

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026