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临床试验/NCT04107701
NCT04107701招募中不适用

Indoor Air Quality and Respiratory Morbidity in School-Aged Children With BPD

Boston Children's Hospital2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2019年7月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
240
试验地点
2
主要终点
Respiratory Morbidity

研究概览

简要总结

Investigators want to learn the role of indoor environmental exposures on respiratory symptoms, and, separately, on lung function deficits in school-aged children with bronchopulmonary dysplasia (BPD).

详细描述

Bronchopulmonary dysplasia (BPD) is the most common respiratory disease affecting children born prematurely and leads to long-term respiratory symptoms and lung function impairment throughout childhood. This study will, evaluate the contribution of indoor sources of respiratory irritants to respiratory health impairment in school-aged children with BPD. State-of-the-art measures of indoor air quality constituents will assess the relationship of nitrogen dioxide (NO2), particulate matter (PM2.5), as well as, concentrations of allergens (mold, mouse, cockroach, pet), endotoxin, air temperature and humidity with concurrently measured respiratory symptoms and lung function in a well-characterized cohort of children with BPD. This research will identify specific harmful components of the indoor environment associated with respiratory morbidity and poor lung function in children with BPD.

Investigators will ask the participants to come in for a one time clinic visit for undergoing procedures as well as answering questions regarding health and home environment. During the 1 year of participation there will also be 2 home assessment visits where investigators will take a sample of the home environment as well record home characteristics.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children 6-12 yrs old
  • born <32 wks gestational age
  • diagnosis of BPD or > 28 days of oxygen or respiratory support

排除标准

  • major airway or chest surgery
  • physical or mental impairment that will prevent from doing spirometry
  • plans to move out of state within the next 9 months

结局指标

主要结局

Respiratory Morbidity

时间窗: 2 weeks

maximum symptom days in the prior 2 weeks assessed at completion of home sampling visits ( Units: days scale: 0-14 days with symptoms, higher is worse

Lung Function

时间窗: 1 yr

Spirometry (FEV1 percent predicted) Units: percent Scale: continuous integers, higher is better

次要结局

  • Lung function(1 year)
  • Lung Function(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonathan M. Gaffin

Principal Investigator, Assistant Professor of Pediatrics

Boston Children's Hospital

研究点 (2)

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