跳至主要内容
临床试验/NCT04152746
NCT04152746已完成不适用

Periostin Levels in Children With Adenoid Hypertrophy

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2019年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
1
主要终点
Serum periostin concentration

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
2 Years 至 8 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •History of allergic rhinitis. History of asthma. Immunodeficiency. Chronic systemic or endocrine disease. Recent upper respiratory tract infection. Previous adenoid surgery.

研究组 & 干预措施

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.

干预措施: Periostin level (Other)

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.

干预措施: Periostin level (Other)

结局指标

主要结局

Serum periostin concentration

时间窗: At baseline, before adenoidectomy

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.

次要结局

  • Periostin concentration in adenoid tissue(During adenoidectomy)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验