Non-invasive Differential Diagnosis of Noisy Breathing Infants and Toddlers

NCT04128592 | Unknown

• 1 other identifier: NiNbI-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Noisy Breathing Infants; Noist Breathing Toddlers; Wheezing; Rattling

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (8)

• Breath sound recordings evaluated by expert panel of pediatricians

  week 0

• Breath sound recordings evaluated by expert panel of pediatricians

  week 3

• Breath sound recordings evaluated by expert panel of pediatricians

  week 6

• Treatment response assessed by online journal for parents

  week 6

• Recurrence of symptoms assessed by follow up questionnaire

  3 months after week 6

Study Arms (2)

Wheezing

OTHER

Device: diagnosing noisy breathing in infants and toddlers

Rattling

OTHER

Device: diagnosing noisy breathing in infants and toddlers

Interventions

diagnosing noisy breathing in infants and toddlers DEVICE

breath sampling and nasal mucus sampling to analyze biomarkers and breath sound analysis to diagnose noisy breathing.

Rattling; Wheezing

Eligibility Criteria

• Age: 2 Months - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• clinical diagnosis of noisy breathing ("wheezing" or "rattling")

You may not qualify if:

• born before pregnancy week 37
• congenital or genetic conditions (Down syndrome, Klinefelter's syndrome, …)
• acquired chronic respiratory diseases (bronchopulmonary dysplasy, lung fibrosis, …)

Sponsors & Collaborators

• Hasselt University: lead
• Jessa Hospital: collaborator
• VITO: collaborator

Study Sites (1)

Jessa Ziekenhuis

Hasselt, 3500, Belgium

RECRUITING

MeSH Terms

Conditions

Respiratory Sounds

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc Raes, prof. dr.

  Jessa Hospital

  PRINCIPAL INVESTIGATOR

• Gitte Slingers, drs.

  Hasselt University

  STUDY CHAIR

Central Study Contacts

Marc Raes, prof. dr.

CONTACT

+32 11 30 84 65; marc.raes@jessazh.be

Gitte Slingers, drs.

CONTACT

+32 11 30 84 65; gitte.slingers@uhasselt.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: October 16, 2019
• Study Start: October 30, 2018
• Primary Completion: March 1, 2020
• Study Completion: May 1, 2020
• Last Updated: October 16, 2019

Record last verified: 2019-10

Locations

BE (1)