An interventional study of diagnosing noisy breathing in infants and toddlers in Noisy Breathing Infants, Noist Breathing Toddlers and Wheezing, sponsored by Hasselt University. Status unknown at 1 site in Belgium. Open to participants aged 2 Months to 18 Months. Per ClinicalTrials.gov, last updated 2019-10-16.
Sponsored by Hasselt University · Not applicable, Interventional, and Diagnostic
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.
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This study's planned enrollment of 100 is above the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.
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Exclusion Criteria:
Device: diagnosing noisy breathing in infants and toddlers
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: week 6
respiratory pathogens
respiratory pathogens present in a nasopharyngeal swab detected using PCR
Time frame: week 0
respiratory pathogens
respiratory pathogens present in a nasopharyngeal swab detected using PCR
Time frame: week 3
respiratory pathogens
respiratory pathogens present in a nasopharyngeal swab detected using PCR
Time frame: week 6
level of inflammation markers
level of inflammation markers in the nasopharyngeal swab using multiplex immune-assay
Time frame: week 0
level of inflammation markers
level of inflammation markers in the nasopharyngeal swab using multiplex immune-assay
Time frame: week 3
level of inflammation markers
level of inflammation markers in the nasopharyngeal swab using multiplex immune-assay
Time frame: week 6
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months after week 6
Plan to share: Undecided
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Hasselt University