NCT06674720

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

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
19mo left

Started May 2025

Typical duration for all trials

Status
not yet recruiting

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 Progress39%
May 2025Dec 2027

First Submitted

Initial submission to the registry

September 30, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 5, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Expected
Last Updated

January 17, 2025

Status Verified

January 1, 2025

Enrollment Period

Same day

First QC Date

September 30, 2024

Last Update Submit

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

Age1 Year - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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: 30844164BACKGROUND
  • Khadgi 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: 37791228BACKGROUND
  • Niedzielski 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: 37045541BACKGROUND
  • Ohuche 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: 38957679BACKGROUND
  • Galic 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

Otitis Media with Effusion

Condition Hierarchy (Ancestors)

Otitis MediaOtitisEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Mohammed Ahmed Salem, Professor

    Assuit University hospital

    STUDY DIRECTOR

Central Study Contacts

Esraa A Mohamed, Bachelor's

CONTACT

Mohamed O Gad, Professor

CONTACT

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