Non-invasive Differential Diagnosis of Noisy Breathing Infants and Toddlers

Wheezing Clinical Trial

— NiNbI  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04128592
• Other study ID #: NiNbI-001
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2018
• Est. completion date: May 2020

Study information

• Verified date: October 2019
• Source: Hasselt University
• Contact: Marc Raes, prof. dr.
• Phone: +32 11 30 84 65
• Email: marc.raes[@]jessazh.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 18 Months

Eligibility

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, …)

Related Conditions & MeSH terms

• Noist Breathing Toddlers
• Noisy Breathing Infants
• Rattling
• Respiratory Aspiration
• Respiratory Sounds
• Wheezing

Intervention

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.

Locations

Country	Name	City	State
Belgium	Jessa Ziekenhuis	Hasselt

Sponsors (3)

Lead Sponsor	Collaborator
Hasselt University	Jessa Hospital, VITO

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Noisy breathing diagnosis made by pediatrician based on anamnesis and auscultation	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.	week 0
Primary	Noisy breathing diagnosis made by pediatrician based on anamnesis and auscultation	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.	week 3
Primary	Noisy breathing diagnosis made by pediatrician based on anamnesis and auscultation	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.	Week 6
Primary	exhaled breath volatiles	exhaled breath volatiles analyzed with Selected Ion Flow Tube Mass Spectrometry (SIFT-MS) and Gas Chromatography Mass Spectrometry (GC-MS)	week 0
Primary	exhaled breath volatiles	exhaled breath volatiles analyzed with Selected Ion Flow Tube Mass Spectrometry (SIFT-MS) and Gas Chromatography Mass Spectrometry (GC-MS)	week 3
Primary	exhaled breath volatiles	exhaled breath volatiles analyzed with Selected Ion Flow Tube Mass Spectrometry (SIFT-MS) and Gas Chromatography Mass Spectrometry (GC-MS)	week 6
Primary	respiratory pathogens	respiratory pathogens present in a nasopharyngeal swab detected using PCR	week 0
Primary	respiratory pathogens	respiratory pathogens present in a nasopharyngeal swab detected using PCR	week 3
Primary	respiratory pathogens	respiratory pathogens present in a nasopharyngeal swab detected using PCR	week 6
Primary	level of inflammation markers	level of inflammation markers in the nasopharyngeal swab using multiplex immune-assay	week 0
Primary	level of inflammation markers	level of inflammation markers in the nasopharyngeal swab using multiplex immune-assay	week 3
Primary	level of inflammation markers	level of inflammation markers in the nasopharyngeal swab using multiplex immune-assay	week 6
Secondary	Breath sound recordings evaluated by expert panel of pediatricians	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.	week 0
Secondary	Breath sound recordings evaluated by expert panel of pediatricians	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.	week 3
Secondary	Breath sound recordings evaluated by expert panel of pediatricians	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.	week 6
Secondary	Treatment response assessed by online journal for parents	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.	week 6
Secondary	Recurrence of symptoms assessed by follow up questionnaire	Online questionnaire asks about noisy breathing symptoms in the past 3 months, their frequency and seriousness. In the online	3 months after week 6
Secondary	Recurrence of symptoms assessed by follow up questionnaire	Online questionnaire asks about noisy breathing symptoms in the past 3 months, their frequency and seriousness. In the online	6 months after week 6
Secondary	Recurrence of symptoms assessed by follow up questionnaire	Online questionnaire asks about noisy breathing symptoms in the past 3 months, their frequency and seriousness. In the online	9 months after week 6
Secondary	Recurrence of symptoms assessed by follow up questionnaire	Online questionnaire asks about noisy breathing symptoms in the past 3 months, their frequency and seriousness. In the online	12 months after week 6