Non-invasive Differential Diagnosis of Noisy Breathing Infants and Toddlers (NiNbI)
Primary Purpose
Noisy Breathing Infants, Noist Breathing Toddlers, Wheezing
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
diagnosing noisy breathing in infants and toddlers
Sponsored by
About this trial
This is an interventional diagnostic trial for Noisy Breathing Infants
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, …)
Sites / Locations
- Jessa ZiekenhuisRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Wheezing
Rattling
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
exhaled breath volatiles
exhaled breath volatiles analyzed with Selected Ion Flow Tube Mass Spectrometry (SIFT-MS) and Gas Chromatography Mass Spectrometry (GC-MS)
exhaled breath volatiles
exhaled breath volatiles analyzed with Selected Ion Flow Tube Mass Spectrometry (SIFT-MS) and Gas Chromatography Mass Spectrometry (GC-MS)
exhaled breath volatiles
exhaled breath volatiles analyzed with Selected Ion Flow Tube Mass Spectrometry (SIFT-MS) and Gas Chromatography Mass Spectrometry (GC-MS)
respiratory pathogens
respiratory pathogens present in a nasopharyngeal swab detected using PCR
respiratory pathogens
respiratory pathogens present in a nasopharyngeal swab detected using PCR
respiratory pathogens
respiratory pathogens present in a nasopharyngeal swab detected using PCR
level of inflammation markers
level of inflammation markers in the nasopharyngeal swab using multiplex immune-assay
level of inflammation markers
level of inflammation markers in the nasopharyngeal swab using multiplex immune-assay
level of inflammation markers
level of inflammation markers in the nasopharyngeal swab using multiplex immune-assay
Secondary Outcome Measures
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.
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.
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.
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.
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
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
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
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
Full Information
NCT ID
NCT04128592
First Posted
August 27, 2019
Last Updated
October 15, 2019
Sponsor
Hasselt University
Collaborators
Jessa Hospital, VITO
1. Study Identification
Unique Protocol Identification Number
NCT04128592
Brief Title
Non-invasive Differential Diagnosis of Noisy Breathing Infants and Toddlers
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 30, 2018 (Actual)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
May 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Jessa Hospital, VITO
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Noisy Breathing Infants, Noist Breathing Toddlers, Wheezing, Rattling
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Wheezing
Arm Type
Other
Arm Title
Rattling
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
diagnosing noisy breathing in infants and toddlers
Intervention Description
breath sampling and nasal mucus sampling to analyze biomarkers and breath sound analysis to diagnose noisy breathing.
Primary Outcome Measure Information:
Title
Noisy breathing diagnosis made by pediatrician based on anamnesis and auscultation
Description
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.
Time Frame
week 0
Title
Noisy breathing diagnosis made by pediatrician based on anamnesis and auscultation
Description
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.
Time Frame
week 3
Title
Noisy breathing diagnosis made by pediatrician based on anamnesis and auscultation
Description
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.
Time Frame
Week 6
Title
exhaled breath volatiles
Description
exhaled breath volatiles analyzed with Selected Ion Flow Tube Mass Spectrometry (SIFT-MS) and Gas Chromatography Mass Spectrometry (GC-MS)
Time Frame
week 0
Title
exhaled breath volatiles
Description
exhaled breath volatiles analyzed with Selected Ion Flow Tube Mass Spectrometry (SIFT-MS) and Gas Chromatography Mass Spectrometry (GC-MS)
Time Frame
week 3
Title
exhaled breath volatiles
Description
exhaled breath volatiles analyzed with Selected Ion Flow Tube Mass Spectrometry (SIFT-MS) and Gas Chromatography Mass Spectrometry (GC-MS)
Time Frame
week 6
Title
respiratory pathogens
Description
respiratory pathogens present in a nasopharyngeal swab detected using PCR
Time Frame
week 0
Title
respiratory pathogens
Description
respiratory pathogens present in a nasopharyngeal swab detected using PCR
Time Frame
week 3
Title
respiratory pathogens
Description
respiratory pathogens present in a nasopharyngeal swab detected using PCR
Time Frame
week 6
Title
level of inflammation markers
Description
level of inflammation markers in the nasopharyngeal swab using multiplex immune-assay
Time Frame
week 0
Title
level of inflammation markers
Description
level of inflammation markers in the nasopharyngeal swab using multiplex immune-assay
Time Frame
week 3
Title
level of inflammation markers
Description
level of inflammation markers in the nasopharyngeal swab using multiplex immune-assay
Time Frame
week 6
Secondary Outcome Measure Information:
Title
Breath sound recordings evaluated by expert panel of pediatricians
Description
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.
Time Frame
week 0
Title
Breath sound recordings evaluated by expert panel of pediatricians
Description
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.
Time Frame
week 3
Title
Breath sound recordings evaluated by expert panel of pediatricians
Description
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.
Time Frame
week 6
Title
Treatment response assessed by online journal for parents
Description
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.
Time Frame
week 6
Title
Recurrence of symptoms assessed by follow up questionnaire
Description
Online questionnaire asks about noisy breathing symptoms in the past 3 months, their frequency and seriousness. In the online
Time Frame
3 months after week 6
Title
Recurrence of symptoms assessed by follow up questionnaire
Description
Online questionnaire asks about noisy breathing symptoms in the past 3 months, their frequency and seriousness. In the online
Time Frame
6 months after week 6
Title
Recurrence of symptoms assessed by follow up questionnaire
Description
Online questionnaire asks about noisy breathing symptoms in the past 3 months, their frequency and seriousness. In the online
Time Frame
9 months after week 6
Title
Recurrence of symptoms assessed by follow up questionnaire
Description
Online questionnaire asks about noisy breathing symptoms in the past 3 months, their frequency and seriousness. In the online
Time Frame
12 months after week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
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, …)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc Raes, prof. dr.
Phone
+32 11 30 84 65
Email
marc.raes@jessazh.be
First Name & Middle Initial & Last Name or Official Title & Degree
Gitte Slingers, drs.
Phone
+32 11 30 84 65
Email
gitte.slingers@uhasselt.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Raes, prof. dr.
Organizational Affiliation
Jessa Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gitte Slingers, drs.
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
Facility Information:
Facility Name
Jessa Ziekenhuis
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gitte Slingers, drs.
Phone
+ 32 11 30 84 65
Email
gitte.slingers@uhasselt.be
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Non-invasive Differential Diagnosis of Noisy Breathing Infants and Toddlers
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