Noisy Breathing InfantsNiNbINCT04128592
Non-invasive Differential Diagnosis of Noisy Breathing Infants and Toddlers
A study testing diagnosing noisy breathing in infants and toddlers in people with Noisy Breathing Infants and Noist Breathing Toddlers, run by Hasselt University at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 2 to 18 months
- Conditions the study is for
- Noisy Breathing Infants, Noist Breathing Toddlers, Wheezing
- What is being tested?
- diagnosing noisy breathing in infants and toddlers
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Oct 2018to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- clinical diagnosis of noisy breathing ("wheezing" or "rattling")
Who cannot join
- born before pregnancy week 37
- congenital or genetic conditions (Down syndrome, Klinefelter's syndrome, …)
- acquired chronic respiratory diseases (bronchopulmonary dysplasy, lung fibrosis, …)
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Jessa Ziekenhuis
Hasselt, 3500
Gitte Slingers, drs., + 32 11 30 84 65, gitte.slingers@uhasselt.be
About this study
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
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.
- Conditions
- Noisy Breathing Infants, Noist Breathing Toddlers, Wheezing, Rattling
- Being tested
- diagnosing noisy breathing in infants and toddlers
- Medical subject headings
- Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnosing noisy breathing in infants and toddlersDevice
breath sampling and nasal mucus sampling to analyze biomarkers and breath sound analysis to diagnose noisy breathing.
| Study group | Role | What they receive |
|---|---|---|
| Wheezing | Other | Not described Receives: Device: diagnosing noisy breathing in infants and toddlers |
| Rattling | Other | Not described Receives: Device: diagnosing noisy breathing in infants and toddlers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: week 6
respiratory pathogens
respiratory pathogens present in a nasopharyngeal swab detected using PCR
Measured: week 0
respiratory pathogens
respiratory pathogens present in a nasopharyngeal swab detected using PCR
Measured: week 3
respiratory pathogens
respiratory pathogens present in a nasopharyngeal swab detected using PCR
Measured: week 6
level of inflammation markers
level of inflammation markers in the nasopharyngeal swab using multiplex immune-assay
Measured: week 0
level of inflammation markers
level of inflammation markers in the nasopharyngeal swab using multiplex immune-assay
Measured: week 3
level of inflammation markers
level of inflammation markers in the nasopharyngeal swab using multiplex immune-assay
Measured: week 6
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months after week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start30 Oct 2018
- Primary completionMar 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Noisy Breathing InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital, VITO
- Responsible party
- Principal investigator, Marc Raes, Hasselt University
- Investigators
- Marc Raes, prof. dr., Principal investigator, Jessa HospitalGitte Slingers, drs., Study chair, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128592
- Sponsor's protocol ID
- NiNbI-001
- Acronym
- NiNbI
- Status last verified
- Oct 2019
- First submitted
- 27 Aug 2019
- Last updated
- 16 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04128592
- Acronym / sponsor ID
- NiNbI / NiNbI-001
- Conditions
- Noisy Breathing Infants, Noist Breathing Toddlers, Wheezing, Rattling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jessa Hospital, VITO
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 16 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wheezing | Other | Device: diagnosing noisy breathing in infants and toddlers |
| Rattling | Other | Device: diagnosing noisy breathing in infants and toddlers |
Who may qualify
- Ages
- 2 to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- clinical diagnosis of noisy breathing ("wheezing" or "rattling")
Key exclusion criteria (3 listed)
- born before pregnancy week 37
- congenital or genetic conditions (Down syndrome, Klinefelter's syndrome, …)
- acquired chronic respiratory diseases (bronchopulmonary dysplasy, lung fibrosis, …)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diagnosing noisy breathing in infants and toddlersbreath sampling and nasal mucus sampling to analyze biomarkers and breath sound analysis to diagnose noisy breathing. | Device | Rattling, Wheezing |
Primary outcome
Noisy breathing diagnosis made by pediatrician based on anamnesis and auscultation
Time frame: week 0
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
Time frame: week 3
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
Time frame: 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
Time frame: week 0
exhaled breath volatiles analyzed with Selected Ion Flow Tube Mass Spectrometry (SIFT-MS) and Gas Chromatography Mass Spectrometry (GC-MS)
exhaled breath volatiles
Time frame: week 3
exhaled breath volatiles analyzed with Selected Ion Flow Tube Mass Spectrometry (SIFT-MS) and Gas Chromatography Mass Spectrometry (GC-MS)
exhaled breath volatiles
Time frame: week 6
exhaled breath volatiles analyzed with Selected Ion Flow Tube Mass Spectrometry (SIFT-MS) and Gas Chromatography Mass Spectrometry (GC-MS)
respiratory pathogens
Time frame: week 0
respiratory pathogens present in a nasopharyngeal swab detected using PCR
respiratory pathogens
Time frame: week 3
respiratory pathogens present in a nasopharyngeal swab detected using PCR
respiratory pathogens
Time frame: week 6
respiratory pathogens present in a nasopharyngeal swab detected using PCR
level of inflammation markers
Time frame: week 0
level of inflammation markers in the nasopharyngeal swab using multiplex immune-assay
level of inflammation markers
Time frame: week 3
level of inflammation markers in the nasopharyngeal swab using multiplex immune-assay
level of inflammation markers
Time frame: week 6
level of inflammation markers in the nasopharyngeal swab using multiplex immune-assay
8 secondary outcomes
Breath sound recordings evaluated by expert panel of pediatricians
Time frame: week 0
Breath sound recordings evaluated by expert panel of pediatricians
Time frame: week 3
Breath sound recordings evaluated by expert panel of pediatricians
Time frame: week 6
Treatment response assessed by online journal for parents
Time frame: week 6
Recurrence of symptoms assessed by follow up questionnaire
Time frame: 3 months after week 6
Recurrence of symptoms assessed by follow up questionnaire
Time frame: 6 months after week 6
Recurrence of symptoms assessed by follow up questionnaire
Time frame: 9 months after week 6
Recurrence of symptoms assessed by follow up questionnaire
Time frame: 12 months after week 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Raes, prof. dr. principal investigator
Jessa Hospital
Gitte Slingers, drs. study chair
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diagnosing noisy breathing in infants and toddlers in people with Noisy Breathing Infants and Noist Breathing Toddlers, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc Raes, prof. dr. (+32 11 30 84 65, marc.raes@jessazh.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Noisy breathing diagnosis made by pediatrician based on anamnesis and auscultation (time frame: week 0). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2019.