Non-invasive Differential Diagnosis of Noisy Breathing Infants and Toddlers

Not Applicable

• Conditions: Noisy Breathing Infants; Noist Breathing Toddlers; Wheezing; Rattling
• Interventions: Device: diagnosing noisy breathing in infants and toddlers

• Registration Number: NCT04128592
• Lead Sponsor: Hasselt University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-30
• Study First Submitted: 2019-08-27
• Status Verified: 2019-10
• Study First Submitted QC: 2019-10-15
• Last Update Submitted: 2019-10-15
• Study First Posted: 2019-10-16
• Last Update Posted: 2019-10-16
• Primary Completion: 2020-03
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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, ...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rattling	diagnosing noisy breathing in infants and toddlers	-
Wheezing	diagnosing noisy breathing in infants and toddlers	-

Primary Outcome Measures

Name	Time	Method
Noisy breathing diagnosis made by pediatrician based on anamnesis and auscultation	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	week 6	exhaled breath volatiles analyzed with Selected Ion Flow Tube Mass Spectrometry (SIFT-MS) and Gas Chromatography Mass Spectrometry (GC-MS)
respiratory pathogens	week 6	respiratory pathogens present in a nasopharyngeal swab detected using PCR
level of inflammation markers	week 6	level of inflammation markers in the nasopharyngeal swab using multiplex immune-assay

Secondary Outcome Measures

Name	Time	Method
Breath sound recordings evaluated by expert panel of pediatricians	week 6	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 continuous over the recording.
Treatment response assessed by online journal for parents	week 6	Parents are asked what type of noisy breathing symptoms their child had during the day. Options are: (1) Wheezing; (2) Rattling; (3) Both, but mostly wheezing; (4) Both, but mostly rattling; (5) Both in equal amounts, (6) No noisy breathing today. In the online questionnaire sound fragments of wheezing and rattling are available incase parents are in doubt.
Recurrence of symptoms assessed by follow up questionnaire	12 months after week 6	Online questionnaire asks about noisy breathing symptoms in the past 3 months, their frequency and seriousness. In the online

Trial Locations

Locations (1)

Jessa Ziekenhuis; 🇧🇪 Hasselt, Belgium