Bronchopulmonary Dysplasia

Researchers are evaluating new imaging techniques in adults aged 18 to 85 with lung diseases such as asthma, emphysema, COPD, bronchiectasis, sarcoidosis, pulmonary fibrosis, alpha 1-anti-trypsin deficiency, and lymphangioleiomyomatosis (LAM). The study aims to develop tools for analyzing lung function and structure using hyperpolarized Xenon 129 MRI alongside pulmonary function tests. This research is supported by Western University, Canada. Participants will undergo a series of tests during a one to two-hour visit, including medical history review, vital signs measurement, full pulmonary function testing following American Thoracic Society guidelines, proton MRI, specialized 129-Xe MRI scans using chest coils, and a low-dose thoracic CT scan. The MRI procedure includes monitoring heart rate and oxygen levels, providing hearing protection, and offering supplemental oxygen as needed. These imaging and testing methods help assess lung ventilation, diffusion, and gas exchange. During the study visit, participants will complete pulmonary function tests such as spirometry, plethysmography, and diffusing capacity tests. They will undergo magnetic resonance imaging with hyperpolarized Xenon gas to visualize lung airways and anatomy, along with CT scans matched to MRI breathing maneuvers. Researchers will measure ventilation defect percent (VDP), apparent diffusion coefficients (ADC), and dissolved phase spectroscopy over five years. Participant safety is monitored throughout the visit, and the total study duration includes these assessments and follow-up measures.

Preterm birth, defined as birth before 37 weeks of gestation, occurs in about 8 percent of pregnancies in Canada and is linked to many health challenges, especially when it happens before 29 weeks. At this early stage, infants often face breathing difficulties and may require resuscitation. This trial compares resuscitation using either low (30%) or high (60%) oxygen levels to determine which approach results in better survival and neurodevelopmental outcomes at around 24 months of age. The study uses a cluster randomized crossover design where hospitals alternate between starting resuscitation with 30% or 60% oxygen for groups of 30 infants. Resuscitation includes standard care steps like lung expansion and ventilation support as needed. Oxygen is initially given at the assigned concentration for the first 5 minutes, then adjusted based on the infant's oxygen saturation levels and heart rate over the next 5 minutes to maintain target saturation ranges. This approach aims to balance risks of too much or too little oxygen. Participants are infants born between 23 and 28 weeks gestation who receive full resuscitation at participating centers. During the study, infants have oxygen saturation monitored continuously, and adjustments to oxygen concentration are made carefully. Researchers will evaluate survival and major neurodevelopmental outcomes at 24 months corrected age, along with several safety and health measures during the neonatal intensive care stay. The trial is expected to provide important evidence to guide oxygen use during resuscitation of extremely preterm infants.

Researchers are evaluating an investigational drug called OHB-607 to prevent Bronchopulmonary Dysplasia (BPD), a common chronic lung disease in extremely premature infants. The study compares infants receiving OHB-607 to those receiving standard neonatal care to see if the drug can reduce the incidence of severe BPD or death by 36 weeks postmenstrual age. This is a Phase 2b, randomized, open-label study involving infants born between 23 weeks 0 days and 27 weeks 6 days gestational age. Participants in the trial will be randomly assigned to one of two groups. One group will receive a continuous intravenous infusion of OHB-607 from birth until 29 weeks and 6 days postmenstrual age. The other group will receive standard neonatal care without the investigational drug. This approach allows researchers to compare the effects of OHB-607 against routine care practices for preventing lung disease in these infants. During the study, infants will be closely monitored through 36 weeks postmenstrual age and up to 24 months corrected age. Researchers will assess lung health, including the incidence and severity of BPD, time to weaning off respiratory support, and other complications such as intraventricular hemorrhage and retinopathy of prematurity. Developmental outcomes will also be measured using standardized scales at 24 months corrected age. Safety assessments and long-term follow-up are included to understand the drug's effects over time.

Researchers are conducting the GENESIS clinical study to map the HLA genomic region in the Greek population and explore its possible links with various underlying diseases. This non-interventional, multicenter study aims to provide a pilot map of genetic variation in HLA that may be useful in medical research and clinical applications related to selected diseases. The study plans to include 12,000 participants over a total duration of 36 months. Each participant will attend one visit at a participating site during which they will provide demographic data, lifestyle information such as smoking and alcohol use, blood pressure measurements, details on diagnosed diseases and treatments, and recent laboratory test results if available. Buccal swab samples will be collected from each participant to extract DNA for HLA genotyping analysis. Selected samples will undergo further whole genome sequencing to investigate associations with autoimmune diseases. Participants will receive a personalized ancestry report after analysis completion. During the study visit, data collection includes demographic and health information, as well as laboratory and clinical test results from the past year. The genetic material from buccal swabs will be stored and processed for genetic analysis. Researchers will measure allele frequency of HLA alleles in the Greek population and assess the prevalence and risk associations of selected HLA-related diseases. The study's total duration is 36 months with results available at the end of this period.

Acute respiratory failure is a serious medical emergency that can quickly lead to death without prompt treatment. Researchers are evaluating a new portable device designed to provide Continuous Positive Airway Pressure (CPAP) support outside of hospital settings. This device aims to be easy to use by non-medical individuals and to improve outcomes for patients experiencing respiratory failure. The study will test the device's effectiveness and usability in two groups: healthy elderly adults who will self-apply the device, and hospitalized patients with mild oxygenation impairment. The device is designed to deliver positive end-expiratory pressure (PEEP) between 4 and 7.5 cmH2O, and its performance will be assessed in real-world clinical settings across three hospitals. Participants will be monitored for up to 2 hours during device use, with assessments including how easy the device is to use, duration of proper pressure delivery, battery consumption and duration, and changes in blood oxygen levels (SpO2). The study will collect data to support the device's future use as a first-aid tool for respiratory failure outside hospitals. The total study duration and follow-up details are not specified.

Researchers are evaluating a new multi-component score called the Readiness for EXtubation score (REXs) to predict when ICU patients on invasive mechanical ventilation are ready to be extubated. The process of liberation from mechanical ventilation involves weaning, readiness assessment, and extubation, with success defined as not needing invasive support within 48 hours. This study focuses on developing and analyzing REXs to help clinicians assess extubation readiness more accurately in critically ill patients. The study involves daily screening of ICU patients undergoing weaning from invasive mechanical ventilation. Data collected include clinical parameters such as arterial blood gases, ventilation settings, sedation and agitation scores, heart rate, hemoglobin levels, nutritional status, and cough strength, among others. Clinicians will anonymously enter data into an electronic case report form to develop and evaluate the REXs score. Patients prepared for extubation will have their readiness assessed using this score. Participants will be monitored during their ICU stay, with data collected on extubation success or failure at 24, 48, and 72 hours after extubation. Researchers will also track length of ICU and hospital stays and mortality outcomes. The study uses routine clinical data, with anonymization to protect patient confidentiality. Statistical methods will analyze associations between clinical factors and extubation outcomes to validate the REXs score’s predictive ability. The total study duration extends until the end of 2026.

Researchers are evaluating the safety and performance of the MOBYBOX System, an extracorporeal cardiopulmonary support device, in patients experiencing cardiac, respiratory, or combined cardiorespiratory failure. The study aims to gather prospective data on how well the device works and its safety profile in real-world use for patients with severe conditions affecting heart and lung function. The MOBYBOX System is used in two configurations: veno-arterial for cardiac or cardiorespiratory failure and veno-venous for severe respiratory failure. The device provides extracorporeal support to help patients whose heart or lungs are failing. The study monitors device performance every 4 hours while patients are receiving extracorporeal membrane oxygenation (ECMO) with the MOBYBOX system and records serious adverse events within 24 hours. Participants will be closely observed during their treatment with the device, with assessments focusing on safety by tracking serious adverse events within 24 hours and mortality within 30 days. Device performance success is also recorded regularly during treatment. The study will continue to follow patients until December 2026, collecting data relevant to the device's safety and effectiveness in supporting heart and lung function in critically ill patients.

Many premature newborns have trouble breathing after birth and receive support with a breathing machine called nasal continuous positive airway pressure (NCPAP). When their breathing worsens despite NCPAP, they may be treated with surfactant medication inserted into the windpipe using either a ventilation tube or a thin catheter. This research is studying the use of video laryngoscopes, which have a camera and display the airway on a screen, compared to standard direct laryngoscopes that require doctors to look directly into the baby's mouth to insert the tube or catheter. The study aims to see if video laryngoscopy improves the success rate of inserting the thin catheter on the first attempt without causing drops in oxygen or heart rate. The study observes infants who need a thin endotracheal catheter inserted for surfactant administration. It compares two approaches: using a video laryngoscope versus a direct laryngoscope during the insertion. This is done across multiple hospitals, each switching from direct to video laryngoscopy over time. The study does not assign which method is used but records which laryngoscope was used for each insertion attempt to compare outcomes. The main focus is on successful first attempts without physiologic instability, as well as secondary measures like number of attempts, duration, oxygen levels, heart rate, and any complications. Participants are newborn infants up to 28 days old who require thin catheter insertion for surfactant treatment and whose parents have consented to share data. Researchers will collect detailed information during and after the insertion attempt, including heart rate, oxygen saturation, duration of the procedure, and any adverse events such as oral trauma or need for chest compressions. Data will be analyzed to evaluate the success and safety of using video versus direct laryngoscopy. The total participation time depends on when the catheter insertion is performed and the follow-up assessments within 72 hours after the procedure.

Many newborn babies experience breathing difficulties that require intubation, a procedure where a tube is inserted into the windpipe to help with breathing support. This trial compares two methods used by doctors to perform intubation: the traditional direct laryngoscopy (DL), where doctors look directly into the baby's mouth with a standard laryngoscope, and video laryngoscopy (VL), which uses a camera and screen to view the windpipe. The study aims to determine if VL leads to more successful first attempts without causing drops in oxygen levels or heart rate compared to DL. The trial uses a stepped-wedge cluster randomized design across multiple hospitals. Initially, each hospital uses the standard DL method for intubation. At randomly assigned intervals, hospitals switch to using the VL device, the C-MAC video laryngoscope, which includes a monitor and special blades. Doctors receive training and practice with this device before switching. Other intubation practices, such as drug use and supplemental oxygen, remain the same throughout the study. Participants in the trial are newborn infants undergoing intubation. Researchers will collect information about intubation attempts, including success rates, oxygen levels, heart rates, and any complications like oral trauma or need for chest compressions. The main outcome is whether babies are successfully intubated on the first try without physiological instability within five minutes. Additional measures include procedure time, number of attempts, and adverse events. Data will be compared between the periods using DL and VL to assess effectiveness and safety over the course of the study, which lasts until August 2026.

Researchers are studying how different doses of opioids affect the diaphragm muscle's ability to generate stronger breathing efforts. This study focuses on adult patients undergoing lower extremity orthopedic surgery and aims to understand how opioid exposure changes diaphragm muscle function during breathing. Participants will be grouped based on receiving low, mid, or high doses of fentanyl, an opioid used for sedation during surgery. They will undergo ultrasound shear wave elastography examinations while performing various breathing techniques to measure muscle stiffness and response at different opioid dose levels. During the study, researchers will measure changes in muscle stiffness using Young's modulus derived from shear wave speed before and 10 minutes after opioid administration. Participants will have these assessments performed during surgery, and the study will monitor respiratory function to evaluate the effects of opioid doses on diaphragm strength and breathing mechanics.