Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06342752 |
Other study ID # |
6007 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
April 2024 |
Est. completion date |
September 2027 |
Study information
Verified date |
March 2024 |
Source |
University Hospital, Antwerp |
Contact |
Inès Ghys, MD |
Phone |
+32 3 265 26 32 |
Email |
ines.ghys[@]uantwerpen.be |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.