Clinical trial NCT04128592: Non-invasive Differential Diagnosis of Noisy Breathing Infants and Toddlers
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Noisy Breathing Infants
Noist Breathing Toddlers
Wheezing
Rattling
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
name: VITO
First posted: 2019-10-16
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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, ...)

Primary outcomes:
measure: Noisy breathing diagnosis made by pediatrician based on anamnesis and auscultation
timeFrame: week 0
measure: Noisy breathing diagnosis made by pediatrician based on anamnesis and auscultation
timeFrame: week 3
measure: Noisy breathing diagnosis made by pediatrician based on anamnesis and auscultation
timeFrame: Week 6
measure: exhaled breath volatiles
timeFrame: week 0
measure: exhaled breath volatiles
timeFrame: week 3
measure: exhaled breath volatiles
timeFrame: week 6
measure: respiratory pathogens
timeFrame: week 0
measure: respiratory pathogens
timeFrame: week 3
measure: respiratory pathogens
timeFrame: week 6
measure: level of inflammation markers
timeFrame: week 0
measure: level of inflammation markers
timeFrame: week 3
measure: level of inflammation markers
timeFrame: week 6
Secondary outcomes:
measure: Breath sound recordings evaluated by expert panel of pediatricians
timeFrame: week 0
measure: Breath sound recordings evaluated by expert panel of pediatricians
timeFrame: week 3
measure: Breath sound recordings evaluated by expert panel of pediatricians
timeFrame: week 6
measure: Treatment response assessed by online journal for parents
timeFrame: week 6
measure: Recurrence of symptoms assessed by follow up questionnaire
timeFrame: 3 months after week 6
measure: Recurrence of symptoms assessed by follow up questionnaire
timeFrame: 6 months after week 6
measure: Recurrence of symptoms assessed by follow up questionnaire
timeFrame: 9 months after week 6
measure: Recurrence of symptoms assessed by follow up questionnaire
timeFrame: 12 months after week 6
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
Study officials:
affiliation: Jessa Hospital
name: Marc Raes, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Gitte Slingers, drs.
role: STUDY_CHAIR
References: