- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04152746
Niveles de periostina en niños con hipertrofia de adenoides
This prospective observational study evaluated serum and tissue periostin levels in children with adenoid hypertrophy. Children with grade 3-4 adenoid hypertrophy who were scheduled for adenoidectomy were compared with children with grade 1 adenoid hypertrophy without symptoms attributable to adenoid enlargement. Serum periostin levels were compared between the two groups. In the adenoidectomy group, periostin levels in adenoid tissue were also compared with paired samples of normal nasopharyngeal mucosa obtained from the same patients. The study aimed to investigate whether periostin may be associated with the development of adenoid hypertrophy and to explore its potential role in local tissue remodeling.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Adenoid hypertrophy (AH) is a common condition in children and may result in nasal obstruction, mouth breathing, sleep-disordered breathing, recurrent upper respiratory symptoms, and other related clinical manifestations. Although allergic inflammation has been proposed as one of the mechanisms contributing to adenoid hypertrophy, the pathophysiological mechanisms underlying tissue enlargement are multifactorial and remain incompletely understood. Periostin is a matricellular protein involved in extracellular matrix organization and tissue remodeling and has been associated with inflammatory and remodeling processes in several airway diseases. However, limited information is available regarding the role of periostin in adenoid hypertrophy.
This prospective observational study was designed to investigate serum and local tissue periostin levels in children with adenoid hypertrophy. The study included children aged 2-8 years who were evaluated for adenoid hypertrophy. The adenoid hypertrophy group consisted of children with grade 3-4 adenoid hypertrophy who were scheduled for adenoidectomy based on their clinical condition. The control group consisted of children with grade 1 adenoid hypertrophy (0-25% nasopharyngeal obstruction) who had no symptoms attributable to adenoid enlargement.
Serum periostin levels were measured in both groups and compared between children with grade 3-4 and grade 1 adenoid hypertrophy. In children undergoing adenoidectomy, adenoid tissue samples were obtained during the clinically indicated surgical procedure. Paired samples of normal nasopharyngeal mucosa were also obtained from the posterior pharyngeal wall of the same patients. Periostin concentrations in adenoid tissue and paired normal nasopharyngeal mucosa were measured and compared using a within-subject paired analysis. No tissue samples were obtained from the control group.
The primary objective was to determine whether serum periostin levels differ between children with clinically significant adenoid hypertrophy and children with grade 1 adenoid hypertrophy without symptoms attributable to adenoid enlargement. A secondary objective was to evaluate whether periostin expression is increased locally in adenoid tissue compared with paired normal nasopharyngeal mucosa in the same patients.
The study was conducted prospectively after obtaining approval from the institutional ethics committee (Approval No. 8/8.11.04.18), and written informed consent was obtained from the legal guardians of all participants. The study was conducted in accordance with the principles of the Declaration of Helsinki.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Fatih
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Istanbul, Fatih, Turquía (Türkiye), 34093
- Bezmialem Vakif University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
The study population consisted of 37 children aged 2-8 years. The study group included 19 children with grade 3-4 adenoid hypertrophy who were scheduled for adenoidectomy due to clinical indications. The control group included 18 children with grade 1 adenoid hypertrophy and no symptoms attributable to adenoid enlargement. All participants had previously documented negative skin prick test results. Children with a history of allergic rhinitis, asthma, immunodeficiency, chronic systemic or endocrine disease, recent upper respiratory tract infection, or prior adenoid surgery were excluded. Serum samples were obtained from all participants, while adenoid tissue and paired normal nasopharyngeal mucosal samples were obtained only from children undergoing adenoidectomy
Descripción
Inclusion Criteria:
Children aged 2-8 years. Children with grade 3-4 adenoid hypertrophy scheduled for adenoidectomy due to clinical indications.
Children with grade 1 adenoid hypertrophy (0-25% nasopharyngeal obstruction) and no symptoms attributable to adenoid enlargement for the control group.
Previously documented negative skin prick test results. Written informed consent obtained from the legal guardians.
Exclusion Criteria:
History of allergic rhinitis. History of asthma. Immunodeficiency. Chronic systemic or endocrine disease. Recent upper respiratory tract infection. Previous adenoid surgery.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: CASE_CONTROL
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Adenoid Hypertrophy (Grade 3-4)
Children aged 2-8 years with grade 3-4 adenoid hypertrophy who were scheduled for adenoidectomy based on their clinical condition. Serum periostin levels were measured in this group. Adenoid tissue and paired normal nasopharyngeal mucosa samples were obtained from the same patients during the clinically indicated surgical procedure for tissue periostin analysis. |
The serum periostin levels were planned to compare between the serum samples that were obtained from the two groups. The evaluation of the periostin levels of adenoid tissue and normal healthy mucosa were also planned. |
|
Control (Grade 1 Adenoid Hypertrophy)
Children aged 2-8 years with grade 1 adenoid hypertrophy (0-25% nasopharyngeal obstruction) who had no symptoms attributable to adenoid enlargement. Serum periostin levels were measured for comparison with the adenoid hypertrophy group. No adenoid tissue samples were obtained from participants in this group. |
The serum periostin levels were planned to compare between the serum samples that were obtained from the two groups. The evaluation of the periostin levels of adenoid tissue and normal healthy mucosa were also planned. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Serum periostin concentration
Periodo de tiempo: At baseline, before adenoidectomy
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Serum periostin levels were measured in children with grade 3-4 adenoid hypertrophy and compared with those in children with grade 1 adenoid hypertrophy without symptoms attributable to adenoid enlargement. |
At baseline, before adenoidectomy
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Periostin concentration in adenoid tissue
Periodo de tiempo: During adenoidectomy
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Periostin concentration in adenoid tissue was measured in children with grade 3-4 adenoid hypertrophy and compared with periostin concentration in paired normal nasopharyngeal mucosa obtained from the same patients. |
During adenoidectomy
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Nazan Degirmenci, Bezmialem Vakif University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 8/8.11.04.2018
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Individual participant-level data will not be shared because of participant privacy and confidentiality considerations. Only aggregate study results will be reported.
Información sobre medicamentos y dispositivos, documentos del estudio
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