Bioclinical Profile of Adenotonsillar Hypertrophy in the Pediatric Population
Analysis of Clinical, Pathologic and Molecular Markers of Adenotonsillar Hypertrophic Disease
1 other identifier
observational
134
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2017
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2017
CompletedFirst Submitted
Initial submission to the registry
May 9, 2018
CompletedFirst Posted
Study publicly available on registry
May 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedApril 16, 2019
April 1, 2019
11 months
May 9, 2018
April 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bioclinical profile of adenotonsillar hypertrophy
Clinical, laboratory, and molecular markers of adenotonsillar hypertrophy
One year post surgical procedure
Secondary Outcomes (5)
Clinical markers of adenotonsillar hypertrophy
One year post surgical procedure
Laboratory markers of adenotonsillar hypertrophy
One year post surgical procedure
Tympanometric findings of middle ear disease resulting from adenotonsillar hypertrophy
One year post surgical procedure
Wide-Band tympanometric findings of middle ear disease resulting from adenotonsillar hypertrophy
One year post surgical procedure
Molecular determinants of adenotonsillar hypertrophy
One year post surgical procedure
Study Arms (4)
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.
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.
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.
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.
Interventions
White blood cell subgroups count
Conventional and multifrequency tympanometry, documenting middle ear admittance and absorbance
Excision of palatine and/or pharyngeal tonsils.
Eligibility Criteria
All children presenting to the clinics of a Pediatric hospital.
You may qualify if:
- Available history and physical exam findings
- Available complete blood count and tympanometry at admission
You may not qualify if:
- Previous tonsillectomy and/or adenoidectomy.
- Previous ear surgery.
- Acute infection during the past month.
- Active severe systemic disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Children Hospital of Patras "Karamandaneio"
Pátrai, Achaia, 26331, Greece
Patras University Hospital
Rio, Achaia, 26504, Greece
Related Publications (5)
Marcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J, Schechter MS, Ward SD, Sheldon SH, Shiffman RN, Lehmann C, Spruyt K; American Academy of Pediatrics. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2012 Sep;130(3):e714-55. doi: 10.1542/peds.2012-1672. Epub 2012 Aug 27.
PMID: 22926176RESULTLiou HC. Regulation of the immune system by NF-kappaB and IkappaB. J Biochem Mol Biol. 2002 Nov 30;35(6):537-46. doi: 10.5483/bmbrep.2002.35.6.537.
PMID: 12470586RESULTHeneghan AF, Pierre JF, Kudsk KA. JAK-STAT and intestinal mucosal immunology. JAKSTAT. 2013 Oct 1;2(4):e25530. doi: 10.4161/jkst.25530. Epub 2013 Jun 26.
PMID: 24416649RESULTMin HJ, Kim SJ, Kim TH, Chung HJ, Yoon JH, Kim CH. Level of secreted HMGB1 correlates with severity of inflammation in chronic rhinosinusitis. Laryngoscope. 2015 Jul;125(7):E225-30. doi: 10.1002/lary.25172. Epub 2015 Jan 30.
PMID: 25639490RESULTKourelis K, Marazioti A, Kourelis T, Stathopoulos GT. Haematologic Markers and Tonsil-to-Body Weight Ratio to Assist Adenotonsillar Hypertrophy Diagnosis. Indian J Otolaryngol Head Neck Surg. 2022 Dec;74(Suppl 3):5604-5610. doi: 10.1007/s12070-021-02943-9. Epub 2021 Oct 25.
PMID: 36742935DERIVED
Biospecimen
Blood was centrifuged and cells were separated from supernatants. Both were stored at -80 degrees. Palatine and pharyngeal tonsillar tissue specimens were divided in half. One part was fixated in 4% formaldehyde for 24 hours and then stored in saline at 4 degrees. The other part was stored immediately at -80 degrees.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Georgios T Stathopoulos
Associate Professor of Physiology
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Physiology
Study Record Dates
First Submitted
May 9, 2018
First Posted
May 30, 2018
Study Start
February 1, 2017
Primary Completion
December 20, 2017
Study Completion
June 30, 2018
Last Updated
April 16, 2019
Record last verified: 2019-04