---
title: Non-invasive Differential Diagnosis of Noisy Breathing Infants and Toddlers
nct_id: NCT04128592
overall_status: UNKNOWN
phase: NA
sponsor: Hasselt University
study_type: INTERVENTIONAL
primary_condition: Noisy Breathing Infants
countries: Belgium
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04128592.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04128592"
ct_last_update_post_date: 2019-10-16
last_seen_at: "2026-05-12T07:20:16.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Non-invasive Differential Diagnosis of Noisy Breathing Infants and Toddlers

**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

**NCT ID:** [NCT04128592](https://clinicaltrials.gov/study/NCT04128592)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 100
- **Lead Sponsor:** Hasselt University
- **Collaborators:** Jessa Hospital, VITO
- **Conditions:** Noisy Breathing Infants, Noist Breathing Toddlers, Wheezing, Rattling
- **Start Date:** 2018-10-30
- **Completion Date:** 2020-05
- **CT.gov Last Update:** 2019-10-16

## 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.

## Eligibility

- **Minimum age:** 2 Months
- **Maximum age:** 18 Months
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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, …)
```

## Arms

- **Wheezing** (OTHER)
- **Rattling** (OTHER)

## 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.

## Primary Outcomes

- **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

## 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)_

## Locations (1)

- Jessa Ziekenhuis, Hasselt, Belgium — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.jessa ziekenhuis|hasselt||belgium` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04128592.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04128592*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*