Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT06674720
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-17
First Post:
2024-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010034', 'term': 'Otitis Media with Effusion'}], 'ancestors': [{'id': 'D010033', 'term': 'Otitis Media'}, {'id': 'D010031', 'term': 'Otitis'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-16', 'studyFirstSubmitDate': '2024-09-30', 'studyFirstSubmitQcDate': '2024-11-03', 'lastUpdatePostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparing presence of middle ear effusion in relation to site and size of adenoid hypertrophy', 'timeFrame': 'Baseline', 'description': 'The incidence of OME with each AH grade occurring in each age group of the sample size.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adenoid Hypertrophy', 'Middle Ear Effusion']}, 'referencesModule': {'references': [{'pmid': '30844164', 'type': 'BACKGROUND', 'citation': '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': '37791228', 'type': 'BACKGROUND', 'citation': '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': '37045541', 'type': 'BACKGROUND', 'citation': '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': '38957679', 'type': 'BACKGROUND', 'citation': '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': '35282481', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nIt 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.\n\nAH 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.\n\nOtitis 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.\n\nAlthough the exact pathogenesis of OME is not clearly understood, it is generally resulted from lymphoid tissue overgrowth in nasopharynx, chronic sinus infection, and allergies.\n\nIt 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.\n\nIt 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.\n\nThere is sufficient evidence that AH is an important co-factor in the development of OME, a very consequential disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children age group (from 1 year old till 16 years old), male and female are included, with symptoms and signs of adenoid hypertrophy', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children (until age of 16 years old).\n* Patients with adenoid hypertrophy.\n* Patients with OME.\n\nExclusion Criteria:\n\n* Children known to have cleft palate, submucous cleft palate or other medical problems causing velopharyngeal insufficiency.\n* Down's syndrome, septal deviation, primary ciliary dyskinesia (Kartagener's syndrome), previous head or ear trauma, or previous myringotomy with ventilation tube insertion\n* Systemic medical problems interfering with surgery.\n* Refusal of parents to participate.\n* Craniofacial abnormalities."}, 'identificationModule': {'nctId': 'NCT06674720', 'briefTitle': '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.', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Correlation of Site and Size of Adenoid Hypertrophy and Middle Ear Effusion.', 'orgStudyIdInfo': {'id': 'Adenoid hypertrophy and MEE'}}, 'contactsLocationsModule': {'centralContacts': [{'name': "Esraa A Mohamed, Bachelor's", 'role': 'CONTACT', 'email': 'esraa.aboalqasem@gmail.com', 'phone': '+201122736706'}, {'name': 'Mohamed O Gad, Professor', 'role': 'CONTACT', 'email': 'Omargad@gmail.com', 'phone': '+201227006258'}], 'overallOfficials': [{'name': 'Mohammed Ahmed Salem, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assuit University hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Esraa Abo Alqasem Mohamed Abd Alnaser', 'investigatorAffiliation': 'Assiut University'}}}}