NCT04128592

Non-invasive Differential Diagnosis of Noisy Breathing Infants and Toddlers

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Hasselt University · Academic / Other
• Sex: All
• Age: 2 Months – 18 Months
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Noisy Breathing Infants
• Noist Breathing Toddlers
• Wheezing
• Rattling

Interventions

Type	Name	Description
DEVICE	diagnosing noisy breathing in infants and toddlers	breath sampling and nasal mucus sampling to analyze biomarkers and breath sound analysis to diagnose noisy breathing.

Timeline

• Start date: 2018-10-30
• Primary completion: 2020-03-01
• Completion: 2020-05-01
• First posted: 2019-10-16
• Last updated: 2019-10-16

Locations

1 site across 1 country: Belgium