NCT06342752 The Role of Volatile Organic Compounds (VOCs), Airway Mucins and the Microbiome in the Early Prediction of Bronchopulmonary Dysplasia (BPD)
| NCT ID | NCT06342752 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Antwerp |
| Condition | Bronchopulmonary Dysplasia |
| Study Type | OBSERVATIONAL |
| Enrollment | 140 participants |
| Start Date | 2024-06-14 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 140 participants in total. It began in 2024-06-14 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Antonius Mulder, MD, PhD,prof
PRINCIPAL INVESTIGATOR
University Hospital Antwerp, Belgium
Frequently Asked Questions
Who can join the NCT06342752 clinical trial?
This trial is open to participants of all sexes, aged 0 Days or older, up to 3 Days, studying Bronchopulmonary Dysplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06342752 currently recruiting?
Yes, NCT06342752 is actively recruiting participants. Contact the research team at ines.ghys@uantwerpen.be for enrollment information.
Where is the NCT06342752 trial being conducted?
This trial is being conducted at Edegem, Belgium.
Who is sponsoring the NCT06342752 clinical trial?
NCT06342752 is sponsored by University Hospital, Antwerp. The principal investigator is Antonius Mulder, MD, PhD,prof at University Hospital Antwerp, Belgium. The trial plans to enroll 140 participants.