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临床试验/NCT04128592
NCT04128592Unknown不适用

Non-invasive Differential Diagnosis of Noisy Breathing Infants and Toddlers Based on Biomarker Profiles in Exhaled Breath and Nasal Mucus and Based on Breath Sound Analysis

Hasselt University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年10月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
Noisy breathing diagnosis made by pediatrician based on anamnesis and auscultation

研究概览

简要总结

Almost 50% of all children have at least 1 episode of noisy breathing before the age of 2 years and almost 25% of these children have more episodes of noisy breathing. The lack of an objective technique for diagnosing noisy breathing children often leads to overrated diagnosis of "wheezing", whereas there may be other noisy breathing phenotypes, like "rattling", that don't favor from the same therapeutic treatment. Presumably, different underlying pathophysiological mechanisms are involved with different biomarker profiles characteristic for different phenotypes. The goal of this study is to optimize the diagnosis of noisy breathing infants and toddlers. Children will be followed for a treatment period of 6 weeks and will visit the paediatrician 3 times (week 0, 3 and 6). During the consultations breath sound analysis will be performed and a breath sample and a nasal mucus will be collected to analyse biomarker profiles. Both methods for diagnosing noisy breathing infants are non-invasive and will be compared to the standard procedure of the paediatrician which consists of auscultation and palpation of the chest. An objective and non-invasive method for diagnosing noisy breathing infants and toddler will pave the way for more cost-effective and personalized prescription of therapies which will increase the quality of life of children with noisy breathing.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
2 Months 至 18 Months(Child)
性别
All
接受健康志愿者

入选标准

  • clinical diagnosis of noisy breathing ("wheezing" or "rattling")

排除标准

  • born before pregnancy week 37
  • congenital or genetic conditions (Down syndrome, Klinefelter's syndrome, ...)
  • acquired chronic respiratory diseases (bronchopulmonary dysplasy, lung fibrosis, ...)

研究组 & 干预措施

Rattling

Other

干预措施: diagnosing noisy breathing in infants and toddlers (Device)

Wheezing

Other

干预措施: diagnosing noisy breathing in infants and toddlers (Device)

结局指标

主要结局

Noisy breathing diagnosis made by pediatrician based on anamnesis and auscultation

时间窗: Week 6

Noisy breathing diagnosis is made by the same pediatrician and is based on intensity and duration of both wheeze and rattle are scored on a scale of 0 to 10, whit 0 indicating not present and 10 indicating very high intensity or of continuous duration.which differentiate "wheezing" and "rattling" infants and toddlers. Comparing diagnosis based on these biomarker profiles to the diagnosis made by the pediatrician based on auscultation and palpation.

exhaled breath volatiles

时间窗: week 6

exhaled breath volatiles analyzed with Selected Ion Flow Tube Mass Spectrometry (SIFT-MS) and Gas Chromatography Mass Spectrometry (GC-MS)

respiratory pathogens

时间窗: week 6

respiratory pathogens present in a nasopharyngeal swab detected using PCR

level of inflammation markers

时间窗: week 6

level of inflammation markers in the nasopharyngeal swab using multiplex immune-assay

次要结局

  • Breath sound recordings evaluated by expert panel of pediatricians(week 6)
  • Treatment response assessed by online journal for parents(week 6)
  • Recurrence of symptoms assessed by follow up questionnaire(12 months after week 6)

研究者

发起方
Hasselt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marc Raes

prof. dr.

Hasselt University

研究点 (2)

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