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The Role of VOCs, Airway Mucins and Airway Microbiome in Bronchopulmonary Dysplasia - Trial NCT06342752

Access comprehensive clinical trial information for NCT06342752 through Pure Global AI's free database. This phase not specified trial is sponsored by University Hospital, Antwerp and is currently Not yet recruiting. The study focuses on Bronchopulmonary Dysplasia. Target enrollment is 140 participants.

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NCT06342752
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diagnostic test
Trial Details
ClinicalTrials.gov โ€ข NCT06342752
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The Role of VOCs, Airway Mucins and Airway Microbiome in Bronchopulmonary Dysplasia
The Role of Volatile Organic Compounds (VOCs), Airway Mucins and Microbiome in the Development of Bronchopulmonary Dysplasia and the Feasibility of Exhaled Breath VOCs Analysis as an Early Detection Tool

Study Focus

Breath test

Observational

diagnostic test

Sponsor & Location

University Hospital, Antwerp

Timeline & Enrollment

N/A

Apr 01, 2024

Sep 01, 2027

140 participants

Primary Outcome

Exhaled breath Volatile Organic Compounds (VOCs),Airway mucin profiles,Airway microbial profiles

Summary

Bronchopulmonary dysplasia (BPD), the most common respiratory complication of extremely
 preterm birth, significantly impacts healthcare with high morbidity and mortality rates.
 
 Despite the well-established primordial role of inflammation and oxidative stress in the
 development of BPD, clinical practice does not incorporate the testing for biomarkers
 associated with the development of BPD. The diagnosis of BPD based on required respiratory
 support at 36 weeks PML, stresses the need for an early prediction tool which could identify
 patients with high levels of these biomarkers. This on its turn, could also improve treatment
 approaches in clinical practice which are currently mostly supportive or non-specific and do
 not target underlying pathophysiologic pathways.
 
 Secondly, mucin expression aim to play a rol in other respiratory diseases, whereas in BPD
 only the potential role of MUC1 was explored.
 
 Thirdly, the composition of the airway microbial composition of an infant is assumed to be
 influenced by different factors. From early on in pregnancy the airway microbiome of the
 infant is formed, offering a protective role against pathologies. On the other hand, the role
 of the airway microbiome in the development of BPD remains unclear and needs to be
 elucidated.
 
 The threefold aim of this study is as follows:
 
 I. The development of a non-invasive breath test that allows early detection of
 bronchopulmonary dysplasia, using the potential of VOCs in exhaled breath as biomarkers for
 inflammation and oxidative stress.
 
 II. The exploration of the composition and diversity of the airway microbiome in infants with
 BPD, their association with exhaled VOCs and the exploration of the placental and vaginal
 microbiome.
 
 III. The detection of potential alterations in airway mucin expression in BPD patients.
 
 Through this comprehensive approach, we seek to gain a deeper understanding of how these
 mutual associations may contribute to the later development of BPD.
 
 In total 140 preterm infants, including 70 BPD patients and 70 preterm controls, born below
 30 weeks' gestation at the Antwerp University Hospital will be included.

ICD-10 Classifications

Bronchopulmonary dysplasia originating in the perinatal period
Congenital bronchomalacia
Bronchopneumonia, unspecified
Other congenital malformations of bronchus
Diseases of bronchus, not elsewhere classified

Data Source

ClinicalTrials.gov

NCT06342752

Non-Device Trial