Bioclinical Profile of Adenotonsillar Hypertrophy in the Pediatric Population

Enlargement of Tonsil or Adenoid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03541434
• Other study ID #: 14/30-09-2016 CHPatras
• Status: Completed
• Start date: February 1, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: April 2019
• Source: University of Patras
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: June 30, 2018
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enlargement of Tonsil or Adenoid
• Hypertrophy

Intervention

Diagnostic Test:
• Complete Blood Count
White blood cell subgroups count
• Tympanometry
Conventional and multifrequency tympanometry, documenting middle ear admittance and absorbance

Procedure:
• Tonsillectomy and/or adenoidectomy
Excision of palatine and/or pharyngeal tonsils.

Locations

Country	Name	City	State
Greece	Children Hospital of Patras "Karamandaneio"	Patras	Achaia
Greece	Patras University Hospital	Rio	Achaia

Sponsors (1)

Lead Sponsor	Collaborator
University of Patras

Country where clinical trial is conducted

Greece, 

References & Publications (4)

Heneghan 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. Review. — View Citation

Liou HC. Regulation of the immune system by NF-kappaB and IkappaB. J Biochem Mol Biol. 2002 Nov 30;35(6):537-46. Review. — View Citation

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 S — View Citation

Min 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. — View Citation

Outcome

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