Longitudinal Observational Study in Prematurely Born Preschool Children: Assessment of Lung Function Parameters (PRE-AR) (PREMATURELY BORN CHILDREN- ASTHMA AND ALLERGIC RHINITIS )
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Forced oscillation technique
研究概览
简要总结
The PRE-AR project is a longitudinal observational study. The primary objective is the assessment of lung function parameters in late preterm preschool children.
详细描述
The PRE-AR project is a longitudinal observational study. The primary objective is the assessment of lung function parameters in late preterm preschool children.
Pulmonary function tests will be performed.
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
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Premature birth < 37 weeks
- •5 years old ≤ Age ≥ 3 years old
- •Control group
- •Inclusion Criteria:
- •Full-term birth
- •5 years old ≤ Age ≥ 3 years old
排除标准
- •of both groups:
- •Pulmonary bronchodysplasia (BDP)
- •Acute respiratory infection
- •Immunological and metabolic system disease
- •Malformation of upper respiratory tract
- •Topical or systemic therapies, with antibiotics, antihistaminics and corticosteroids, in the previous 30 days
- •Patients with neurological pathologies
- •Patients that are not able to perform the lung function tests
研究组 & 干预措施
59 prematurely born children
Lung function assessment of 59 prematurely born children (of both sex and 3-5 years old) attending as outpatient clinic of Pediatric Allergology & Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR)
干预措施: Lung Function Assessment (Other)
93 full-term born children
Lung function assessment of a Control group of full-term born children (N=93), recruited by a collaborative Pediatricians network within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy.
干预措施: Lung Function Assessment (Other)
结局指标
主要结局
Forced oscillation technique
时间窗: Baseline, 24 months, and 48 months
Longitudinal assessment of forced oscillation technique (FOT)
Interrupter resistance
时间窗: Baseline, 24 months, and 48 months
Longitudinal assessment of interrupter resistance (RINT)
Spirometry
时间窗: Baseline, 24 months, and 48 months
Longitudinal assessment of spirometry
次要结局
- Urine analysis(Baseline, 24 months, and 48 months)
- Nasal nitric oxide(Baseline, 24 months, and 48 months)
- Atopy(Baseline)
- Nasal brushing(Baseline)
- Saliva sample(24 months, and 48 months)
研究者
Stefania La Grutta, MD
Stefania La Grutta, MD. Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.
Istituto per la Ricerca e l'Innovazione Biomedica