Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342752
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-13
Brief Title:
The Role of VOCs Airway Mucins and Airway Microbiome in Bronchopulmonary Dysplasia
Sponsor:
University Hospital Antwerp
Organization:
University Hospital Antwerp
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INFANCY
Brief 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
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
Detailed Description:
After birth a swab and samples will be collected from the placenta next to a maternal vaginal swab for microbiome analysis Breath samples two oropharyngeal swabs and endotracheal aspirates - in case intubated - will be collected from the infant on different days in the first 28 days of life
At 36 weeks PMA BPD is diagnosed if the infant still requires respiratory support Infants diagnosed with BPD will undergo a one-time capillary or venous blood gas test to assess the degree of severity of lung damage ie grade of alveolar hypoventilation by means of hypercapnia
All enrolled participants regardless of BPD diagnosis will have two clinical follow-up study visits after discharge to home At 6 months corrected age a chest CT will be performed in severe BPD-cases to assess lung structure
At 36 weeks PMA BPD is diagnosed if the infant still requires respiratory support Infants diagnosed with BPD will undergo a one-time capillary or venous blood gas test to assess the degree of severity of lung damage ie grade of alveolar hypoventilation by means of hypercapnia
All enrolled participants regardless of BPD diagnosis will have two clinical follow-up study visits after discharge to home At 6 months corrected age a chest CT will be performed in severe BPD-cases to assess lung structure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None