- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06342752
The Role of VOCs, Airway Mucins and Airway Microbiome in Bronchopulmonary Dysplasia (INFANCY)
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
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.
Study Overview
Status
Conditions
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, i.e. 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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Inès Ghys, MD
- Phone Number: +32 3 265 26 32
- Email: ines.ghys@uantwerpen.be
Study Contact Backup
- Name: Kristien Vanhaverbeke, MD, PhD
- Email: kristien.vanhaverbeke@uantwerpen.be
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Born at a gestational age < 30 weeks
Exclusion Criteria:
- Major congenital defect or disorder
- Patients with an unstable general condition as deemed by the attending neonatologist
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Preterm infants
all included infants will undergo a breath test and two throat swabs, in case the infant is intubated also endotracheal aspirates will be collected
|
Early detection of volatile organic compounds (VOCs) in breath from preterm infants, collected at several timepoints within the first 4 weeks of life to predict BPD before diagnosis is made at 36 weeks PMA.
Other Names:
A throat swab will be taken on several timepoints within the first 4 weeks of life to detect airway mucin expression.
A second throat swab will be taken as proxy for the airway microbiome.
Collection of aspirates, as part of routine care, to detect mucin expression and the lung microbiome.
Other Names:
|
Mothers of preterm infants
placental biopsies, a placental swab and a vaginal swab will be taken after birth
|
After birth, placental biopsies will be collected for headspace VOCs analysis.
A placental swab and a biopsy will be taken for microbiome analysis.
Other Names:
A vaginal swab will be taken before birth for microbiome analysis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exhaled breath Volatile Organic Compounds (VOCs)
Time Frame: first 4 weeks of life
|
Abbundance of VOCs in breath samples to distinguish BPD from preterm controls by means of GC-MS
|
first 4 weeks of life
|
Airway mucin profiles
Time Frame: first 4 weeks of life
|
Genetic expression of airway mucins in BPD and preterm controls on oropharyngeal samples via qRT-PCR
|
first 4 weeks of life
|
Airway microbial profiles
Time Frame: first 4 weeks of life
|
Metagenomic shotgun sequencing after extraction of bacterial DNA from oropharyngeal swabs in BPD and preterm controls
|
first 4 weeks of life
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Placental headspace VOCs
Time Frame: at delivery
|
Abbundance of VOCs in the headspace of placental samples to distinguish BPD from preterm controls
|
at delivery
|
Placental microbiome
Time Frame: at delivery
|
Metagenomic shotgun sequencing after extraction of bacterial DNA from samples and subamniotic swabs after birth
|
at delivery
|
Vaginal microbiome
Time Frame: right before delivery
|
Metagenomic shotgun sequencing after extraction of bacterial DNA from vaginal swabs after birth
|
right before delivery
|
Follow-up structural lung imaging
Time Frame: 9 months
|
Chest CT scan in severe BPD cases
|
9 months
|
Hypercapnia
Time Frame: 3 months
|
BPD patients will undergo a blood gas test to assess the degree of lung damage severity
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Antonius Mulder, MD, PhD,prof, University Hospital Antwerp, Belgium
- Study Director: Stijn L Verhulst, MD, PhD,prof, University Hospital Antwerp, Belgium
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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