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临床试验/NCT07431021
NCT07431021招募中不适用

Children's Health, Respiratory Inflammation and Short-term Air Pollution

Queen Mary University of London1 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2025年10月20日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
330
试验地点
1
主要终点
"Airway resistance" measured by Oscillometry at R5

研究概览

简要总结

The goal of this study is to see if physical activity in high air pollution is worse than rest in high air pollution.

详细描述

The study will recruit a total of 330 children from 10 primary schools split into two groups: "higher pollution" and "lower pollution" schools. The team shall invite children in years 3 to 6 to take part in the study and consent will be provided by parents following information sheets sent home in school bags and parent evening presentations.

After the team have received written permission from parents. The study team will visit the school on two days. On the first day the study team will perform lung health assessment in a dedicated classroom. The assessment will involve, measuring children's height and weight, a breathing test (photo and a snot sample collected by squirting a small bit of saline water up one nostril and catching the snot in a cup.

Children will then take part in a PE lesson or a sedentary science lesson in a random order in their school playground while wearing activity monitors - like a Fitbit- to track their physical activity. The session is designed to be just like a typical outdoor science or PE lesson and will be exactly the same at all schools. Air pollution levels in the playground will be monitored during this time.

Once the PE lesson has finished the children will perform the same health assessment immediately after the lesson and again on a second day. The team shall compare the change in these scores between higher and lower pollution schools. The breathing tests will tell us if the has been any change in lung health and the snot samples will tell us about the pollution the children have breathed and how their bodies try to fight it. Participating will take about 4 hours total.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
7 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Attending schools in Central and East London that have been recruited to the study

排除标准

  • Not able to engage with PE lessons on safety grounds, reported by their parents.
  • Children with learning or physical disabilities sufficient for them to be unable to give informed assent to the study, or to carry out study procedures

研究组 & 干预措施

Physical activity

Experimental

PE Lesson

干预措施: PE Lesson (Behavioral)

Sedenary

Active Comparator

Science lesson

干预措施: science lesson (Behavioral)

结局指标

主要结局

"Airway resistance" measured by Oscillometry at R5

时间窗: Pre-24 hour post exposure

measured as oscillometery R5

次要结局

  • "Small airway resistance" measured by Oscillometry at R5-20(pre- 24 hour post exposure)
  • Immune responses as measured by Il6 in nasal lavage(pre-24 hour post exposure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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