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Not yet recruitingNCT06674720Updated Jan 17, 2025

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.

An observational study in Adenoid Hypertrophy and Middle Ear Effusion, sponsored by Assiut University. Not yet recruiting. Open to participants aged 1 Year to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-17.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 6 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
1 Year to 16 Years
Sex
All
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Study 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.

Read the detailed description

The adenoid, or the pharyngeal tonsil, is an antibody producing lymphatic tissue located in the superior part of the nasopharynx posteriorly, near the choana and opening of the eustachian tube. They are present from the seventh month of gestation and typically grow until age 5. Adenoid tissue can be found extending to the eustachian tube opening and the fossa of Rosenmuller. The fossa of Rosenmuller is on the lateral wall of the nasopharynx, just behind the cartilage of the eustachian tube.

It grows during childhood, appearing largest in size in children between 3 and 7 years of age, and begins to regress in adolescence. Children younger than 7 years are more prone to symptomatic effects of enlarged adenoid due to the relatively smaller volume of the nasopharynx and choanal opening. The prevalence of AH (pathologic enlargement) follows physiologic growth and regression pattern of the adenoid. An enlarged adenoid may block breathing and be a cause of snoring or obstructive sleep apnea. Adenoid hypertrophy can also lead to comorbid conditions such as serous otitis and sinusitis. AH is higher in frequency in children with allergic diseases, with the most common allergen being house dust. Other risk factors noted for developing AH include cigarette smoke exposure and allergic rhinitis. In a child with these risk factors, AH should be a consideration during a routine examination. Assessing adenoidal size can be achieved initially by lateral neck radiography (LNR) and assessing adenoid-nasopharyngeal ratio (A/N ratio) which is one of the most important and most widely used criteria. Although these methods are inexpensive and available, they have limited role in the exact assessment of areas such as the ears. Flexible nasal endoscopy, where adenoid size grading is on a scale of I to IV identifies the percentage of the posterior choana blocked by the adenoid tissue, with grade IV representing the highest level of obstruction.

AH influence on the pathogenesis of OME is two-fold: it may mechanically obstruct the Eustachian tube, and its vegetation may serve as a reservoir of biofilm forming bacteria causing retrograde infections towards the Eustachian tube and the middle ear.

Otitis media with effusion (OME) is a disease defined by persistence of serous or mucous fluid in middle ear without signs of an acute infection. It is amongst the most common pediatric diseases and the most common cause of hearing loss in children. It is estimated that more than 50% of children are diagnosed with OME by the age of 1 year, and up to 90% of children by the time they have reached school age.

Although the exact pathogenesis of OME is not clearly understood, it is generally resulted from lymphoid tissue overgrowth in nasopharynx, chronic sinus infection, and allergies.

It is accepted that adenoid hypertrophy (AH) is related to OME 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.

It is accepted that adenoid hypertrophy (AH) is related to OME 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.

There is sufficient evidence that AH is an important co-factor in the development of OME, a very consequential disease.

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Conditions studied

  • Adenoid Hypertrophy
  • Middle Ear Effusion
03

In context

Otitis Media with Effusion

88 studies on the registry are indexed under Otitis Media with Effusion; 17 are open to participants now.

This study's planned enrollment of 60 is below the median of 150 across 21 observational studies indexed under Otitis Media with Effusion.

Browse Otitis Media with Effusion studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year to 16 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Children (until age of 16 years old).
  • Patients with adenoid hypertrophy.
  • Patients with OME.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
06

What researchers measure

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.

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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/ PubMed 30844164 ↗
  • 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. PubMed 37791228 ↗
  • 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. PubMed 37045541 ↗
  • 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. PubMed 38957679 ↗
  • 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. PubMed 35282481 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2025; primary completion for May 2025, 0 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 30, 2024
First posted
Nov 5, 2024
StartEst.
May 2025
Primary completionEst.
May 2025
CompletionEst.
Dec 2027
Last update
Jan 17, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06674720
Lead sponsor
Assiut University
Responsible party
Esraa Abo Alqasem Mohamed Abd Alnaser (Resident, Assiut University) — Principal investigator
First posted
Nov 5, 2024
Start date
May 2025 (estimated)
Primary completion
May 2025 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jan 17, 2025

Study contacts

Esraa A Mohamed, Bachelor's
Contact
esraa.aboalqasem@gmail.com
+201122736706
Mohamed O Gad, Professor
Contact
Omargad@gmail.com
+201227006258
Mohammed Ahmed Salem, Professor
study director · Assuit University hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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