Non-invasive Differential Diagnosis of Noisy Breathing Infants and Toddlers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-30

Study Completion Date

2020-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Noisy Breathing Infants Noist Breathing Toddlers Wheezing Rattling

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Wheezing

Group Type OTHER

diagnosing noisy breathing in infants and toddlers

Intervention Type DEVICE

breath sampling and nasal mucus sampling to analyze biomarkers and breath sound analysis to diagnose noisy breathing.

Rattling

Group Type OTHER

diagnosing noisy breathing in infants and toddlers

Intervention Type DEVICE

breath sampling and nasal mucus sampling to analyze biomarkers and breath sound analysis to diagnose noisy breathing.

Interventions

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diagnosing noisy breathing in infants and toddlers

breath sampling and nasal mucus sampling to analyze biomarkers and breath sound analysis to diagnose noisy breathing.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

2 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No