Non-invasive Differential Diagnosis of Noisy Breathing Infants and Toddlers (NiNbI)

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

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.

Study Overview

• Status: Unknown
• Conditions: Wheezing; Noisy Breathing Infants; Noist Breathing Toddlers; Rattling
• Intervention / Treatment: Device: diagnosing noisy breathing in infants and toddlers

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marc Raes, prof. dr.; Phone Number: +32 11 30 84 65; Email: marc.raes@jessazh.be
• Study Contact Backup: Name: Gitte Slingers, drs.; Phone Number: +32 11 30 84 65; Email: gitte.slingers@uhasselt.be

Study Locations

• Belgium
  • Hasselt, Belgium, 3500
    • Recruiting
    • Jessa Ziekenhuis
    • Contact: Gitte Slingers, drs.; Phone Number: + 32 11 30 84 65; Email: gitte.slingers@uhasselt.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Wheezing	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.
Other: Rattling	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
respiratory pathogens	respiratory pathogens present in a nasopharyngeal swab detected using PCR	week 0
respiratory pathogens	respiratory pathogens present in a nasopharyngeal swab detected using PCR	week 3
respiratory pathogens	respiratory pathogens present in a nasopharyngeal swab detected using PCR	week 6
level of inflammation markers	level of inflammation markers in the nasopharyngeal swab using multiplex immune-assay	week 0
level of inflammation markers	level of inflammation markers in the nasopharyngeal swab using multiplex immune-assay	week 3
level of inflammation markers	level of inflammation markers in the nasopharyngeal swab using multiplex immune-assay	week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: Jessa Hospital; VITO
• Investigators: Principal Investigator: Marc Raes, prof. dr., Jessa Hospital; Study Chair: Gitte Slingers, drs., Hasselt University

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2018
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: August 27, 2019
• First Submitted That Met QC Criteria: October 15, 2019
• First Posted (Actual): October 16, 2019

Study Record Updates

• Last Update Posted (Actual): October 16, 2019
• Last Update Submitted That Met QC Criteria: October 15, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Aspiration; Respiratory Sounds
• Other Study ID Numbers: NiNbI-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No