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Completed

NCT Number: NCT03541434

Bioclinical Profile of Adenotonsillar Hypertrophy in the Pediatric Population

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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Key information

Age range

1 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children Hospital of Patras "Karamandaneio", Pátrai, Achaia, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Complete blood count

Diagnostic Test

White blood cell subgroups count

Tympanometry

Diagnostic Test

Conventional and multifrequency tympanometry, documenting middle ear admittance and absorbance

Tonsillectomy and/or adenoidectomy

Procedure

Excision of palatine and/or pharyngeal tonsils.

Primary outcomes

  1. Bioclinical profile of adenotonsillar hypertrophy

    Time frame: One year post surgical procedure

    Clinical, laboratory, and molecular markers of adenotonsillar hypertrophy

Secondary outcomes

  1. Clinical markers of adenotonsillar hypertrophy

    Time frame: One year post surgical procedure

    Clinical findings from history (sympoms) and physical exam (signs) suggestive of adenotonsillar hypertrophy.

  2. Laboratory markers of adenotonsillar hypertrophy

    Time frame: One year post surgical procedure

    Complete blood count (cells/L)

  3. Tympanometric findings of middle ear disease resulting from adenotonsillar hypertrophy

    Time frame: One year post surgical procedure

    Middle ear pressure (dekaPascals)

  4. Wide-Band tympanometric findings of middle ear disease resulting from adenotonsillar hypertrophy

    Time frame: One year post surgical procedure

    Resonance frequency of the middle ear (Hz)

  5. Molecular determinants of adenotonsillar hypertrophy

    Time frame: One year post surgical procedure

    Immunohistochemical expression of molecular factors involved in tissue growth (semiquantitative scale)

Sponsors and collaborators

Lead sponsor

University of Patras

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
May 30, 2018
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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