Non-invasive Differential Diagnosis of Noisy Breathing Infants and Toddlers (NiNbI)

Hasselt University

Status: Unknown

Conditions: Wheezing; Rattling; Noist Breathing Toddlers; Noisy Breathing Infants

Treatments: Device: diagnosing noisy breathing in infants and toddlers

Study type: Interventional

Funder types: Other

Identifiers

NCT04128592

NiNbI-001

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 2 to 18 months old

Volunteers: No Healthy Volunteers

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, ...)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Wheezing

Other group

Treatment:

Device: diagnosing noisy breathing in infants and toddlers

Rattling

Other group

Treatment:

Device: diagnosing noisy breathing in infants and toddlers