It is Accepted That Adenoid Hypertrophy is Related to Otitis Media With Effusion Incidence. Better Understanding of the Correlation Between the Relative Size of AH and the Incidence of Persistent OME May Provide Evidence to Support a More Standardized Approach to the Diagnosis and Treatment of OME.
Correlation of Site and Size of Adenoid Hypertrophy and Middle Ear Effusion.
1 other identifier
observational
60
0 countries
N/A
Brief Summary
The aim of this study is to further investigate the correlation between Site and size of adenoid hypertrophy and middle ear effusion in order to provide evidence for designing a more standardized approach to the diagnosis and treatment of OME.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2025
Typical duration for all trials
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
First Submitted
Initial submission to the registry
September 30, 2024
CompletedFirst Posted
Study publicly available on registry
November 5, 2024
CompletedStudy Start
First participant enrolled
May 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
ExpectedJanuary 17, 2025
January 1, 2025
Same day
September 30, 2024
January 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Comparing presence of middle ear effusion in relation to site and size of adenoid hypertrophy
The incidence of OME with each AH grade occurring in each age group of the sample size.
Baseline
Eligibility Criteria
Children age group (from 1 year old till 16 years old), male and female are included, with symptoms and signs of adenoid hypertrophy
You may qualify if:
- Children (until age of 16 years old).
- Patients with adenoid hypertrophy.
- Patients with OME.
You may not qualify if:
- Children known to have cleft palate, submucous cleft palate or other medical problems causing velopharyngeal insufficiency.
- Down's syndrome, septal deviation, primary ciliary dyskinesia (Kartagener's syndrome), previous head or ear trauma, or previous myringotomy with ventilation tube insertion
- Systemic medical problems interfering with surgery.
- Refusal of parents to participate.
- Craniofacial abnormalities.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (5)
Mnatsakanian A, Heil JR, Sharma S. Anatomy, Head and Neck: Adenoids. 2023 Jul 24. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK538137/
PMID: 30844164BACKGROUNDKhadgi A, Koirala K, Maharjan S, Chalise K, Dhungana I, Babu Karki B. Correlation of Conductive Hearing Impairment With Sizes of Adenoids in the Pediatric Age Group: An Observational Case-Control Study. Cureus. 2023 Aug 31;15(8):e44439. doi: 10.7759/cureus.44439. eCollection 2023 Aug.
PMID: 37791228BACKGROUNDNiedzielski A, Chmielik LP, Mielnik-Niedzielska G, Kasprzyk A, Boguslawska J. Adenoid hypertrophy in children: a narrative review of pathogenesis and clinical relevance. BMJ Paediatr Open. 2023 Apr;7(1):e001710. doi: 10.1136/bmjpo-2022-001710.
PMID: 37045541BACKGROUNDOhuche IO, Iloanusi NI, Dike CM, Chime EN. Clinical presentation, radiographic findings, and treatment outcomes in children with adenoid hypertrophy in a paediatric outpatient clinic in Enugu, Nigeria. Ghana Med J. 2023 Sep;57(3):204-209. doi: 10.4314/gmj.v57i3.7.
PMID: 38957679BACKGROUNDGalic MZ, Klancnik M. ADENOID SIZE IN CHILDREN WITH OTITIS MEDIA WITH EFFUSION. Acta Clin Croat. 2022 Feb;60(3):532-539. doi: 10.20471/acc.2021.60.03.25.
PMID: 35282481BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mohammed Ahmed Salem, Professor
Assuit University hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident
Study Record Dates
First Submitted
September 30, 2024
First Posted
November 5, 2024
Study Start
May 1, 2025
Primary Completion
May 1, 2025
Study Completion (Estimated)
December 1, 2027
Last Updated
January 17, 2025
Record last verified: 2025-01