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NCT Number: NCT06674720

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.

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.

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Key information

Age range

1 year–16 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Treatment and study plan

Primary outcomes

  1. Comparing presence of middle ear effusion in relation to site and size of adenoid hypertrophy

    Time frame: Baseline

    The incidence of OME with each AH grade occurring in each age group of the sample size.

Study contacts

Contact information is provided by the study sponsor or research team.

Esraa A Mohamed, Bachelor's

CONTACT

[email protected]

+201122736706

Mohamed O Gad, Professor

CONTACT

[email protected]

+201227006258

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Correlation of Site and Size of Adenoid Hypertrophy and Middle Ear Effusion.

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Nov 5, 2024
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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