Bioclinical Profile of Adenotonsillar Hypertrophy in the Pediatric Population

April 15, 2019 updated by: Georgios Stathopoulos, University of Patras

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

134

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Achaia
      • Patras, Achaia, Greece, 26331
        • Children Hospital of Patras "Karamandaneio"
      • Rio, Achaia, Greece, 26504
        • Patras University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All children presenting to the clinics of a Pediatric hospital.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy
Children with no history of adenotonsillar hypertrophy, recurrent tonsillitis, or middle ear effusion. They presented to the clinic for examination or a scheduled procedure.
Diagnostic test: Complete Blood Count
White blood cell subgroups count
Diagnostic test: Tympanometry
Conventional and multifrequency tympanometry, documenting middle ear admittance and absorbance
Recurrent tonsillitis
Children with a history of recurret tonsillitis but no adenotonsillar hypertrophy. Diagnosis was based on physical exam and complete blood count. They presented to the clinic for a sceduled tonsillectomy.
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.
Middle ear effusion
Children with chronic middle ear effusion but no adenotonsillar hypertrophy. Diagnosis was based on physical exam and tympanometry. They presented to the clinic for scheduled myringotomy with or without adenoidectomy.
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.
Adenotonsillar hypertrophy
Children with tonsillar and/or adenoidal hypertrophy. Diagnosis was based on physical exam and partly on x-ray of nasopharynx or nasopharyngoscopy. They presented to the clinic for scheduled tonsillectomy and/or adenoidectomy.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bioclinical profile of adenotonsillar hypertrophy
Time Frame: One year post surgical procedure
Clinical, laboratory, and molecular markers of adenotonsillar hypertrophy
One year post surgical procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One year post surgical procedure
Laboratory markers of adenotonsillar hypertrophy
Time Frame: One year post surgical procedure
Complete blood count (cells/L)
One year post surgical procedure
Tympanometric findings of middle ear disease resulting from adenotonsillar hypertrophy
Time Frame: One year post surgical procedure
Middle ear pressure (dekaPascals)
One year post surgical procedure
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)
One year post surgical procedure
Molecular determinants of adenotonsillar hypertrophy
Time Frame: One year post surgical procedure
Immunohistochemical expression of molecular factors involved in tissue growth (semiquantitative scale)
One year post surgical procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Patras

Investigators

  • Principal Investigator: Georgios T Stathopoulos, Associate Professor of Physiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

December 20, 2017

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

May 9, 2018

First Submitted That Met QC Criteria

May 29, 2018

First Posted (Actual)

May 30, 2018

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 15, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14/30-09-2016 CHPatras

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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