Neonatal Sepsis

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 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 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 the physical, nutritional, pulmonary, and mental health of females with cystic fibrosis (CF) who are planning pregnancy, are pregnant, or in early parenthood. They are also examining the health of their children from infancy through early childhood to see if new screening or care methods should be included in clinical guidelines. This observational study focuses on the impact of pregnancy and parenthood in the era of CFTR modulators, treatments that target the cause of CF. The study, called MATRIARCH_CF, includes three related sub-studies: "Mama" follows females with CF aged 16 or older who are planning pregnancy or pregnant, involving up to eight visits with tests like blood work, lung function, imaging, and interviews. "Mini" enrolls biological offspring from birth to age two, with up to four visits including blood tests, sweat tests, and brain ultrasounds. "Midi" studies children aged three to six with up to two visits involving lung function tests and lung MRI. The study does not provide or change treatments but monitors health through these investigations. Participants will attend multiple visits for physical and psychological assessments, including lung function, imaging, and blood tests for mothers, and various tests for children depending on their age group. Researchers will measure outcomes such as lung function changes, pulmonary complications during pregnancy, premature deliveries, liver dysfunction, congenital abnormalities, and CF diagnoses in children. The study aims to gather detailed health information over several years without altering clinical care, lasting up to three years for some outcomes.

This research aims to compare two breathing support methods after planned extubation in patients with systolic heart failure who need invasive mechanical ventilation. The study focuses on people who have a heart condition with an ejection fraction of 40% or less and are admitted to intensive care units. It seeks to find out which method better prevents the need for reintubation or respiratory failure after removing the breathing tube. Participants will be randomly assigned to one of two groups after planned extubation: one group will receive continuous therapy using high-flow nasal cannula (HFNC) for 24 hours at the highest tolerated flow level, and the other group will receive non-invasive ventilation (NIV) with set ventilator settings for 24 hours. The study will take place at the Yale New Haven Hospital and is open-label, meaning both patients and researchers know the assigned treatment. During the study, researchers will monitor the rates of reintubation or respiratory failure within 72 hours after extubation as the primary outcome. Additional assessments include rates of respiratory failure at different time points, patient tolerance to treatments, length of hospital stay, ICU and hospital mortality, time to reintubation, and oxygenation measurements. Participants will be closely observed during the first 24 hours of treatment and followed up to 30 days post-extubation to gather comprehensive data on outcomes and safety.

Researchers are conducting a study called Acutelines, a large data and biobank project at the University Medical Center Groningen in the Netherlands. It focuses on patients with a wide range of acute medical conditions who present to the Emergency Department. The goal is to improve how acute diseases are recognized and treated, understand their outcomes, and support personalized medicine by collecting detailed clinical data, imaging, and biomaterials over time. Participants have their medical information, including demographics, health status, medical history, vital signs, diagnostic tests, and treatments, systematically collected. Biomaterials such as blood, urine, feces, and hair are gathered from patients who meet certain severity criteria. Data collection occurs during hospital admission, including continuous monitoring, and continues with follow-ups at 3 months, 1 year, 2 years, and 5 years after the initial emergency visit. Throughout the study, various assessments are performed, such as quality of life, physical functioning, mental health, symptoms, and hospital length of stay. Researchers collect data on mortality and other health outcomes for up to 50 years. The study uses digital tools to automate data capture and integrates information from multiple healthcare sources. Participants will be monitored closely during hospitalization and at scheduled intervals afterward to help improve understanding and treatment of acute diseases.

This research aims to evaluate a new advanced wireless skin sensor system designed to monitor vital signs in healthy newborn infants of at least 35 weeks gestational age. The study focuses on assessing the feasibility, safety, and accuracy of this wireless system compared to the standard wired monitoring during the first two hours after birth, especially during unsupervised parental care in the obstetrical center. The goal is to improve early detection and prevention of Sudden Unexpected Postnatal Collapse (SUPC), a rare but serious condition affecting newborns shortly after delivery. Participants will have both the wireless monitoring system and the standard wired system placed on their chest and limb. For vaginal births, the wireless system is placed first, followed by the wired system after 15-20 minutes; for C-section births, the order of placement is randomized. Both monitoring systems remain in place for two hours to continuously record vital signs such as heart rate, respiratory rate, oxygen saturation, and skin temperature. During the study, newborns' vital signs will be recorded and compared between the two systems for up to two hours immediately after delivery. Researchers will evaluate the feasibility by checking for gaps in data and user satisfaction, assess safety through skin and pain scores, and measure accuracy using statistical comparisons. The study also includes monitoring the time between sensor placement and data display. Participation lasts only the initial two-hour period after birth, with monitoring done under real-world conditions in the obstetrical center.

The goal of a pilot study is to test a study plan to see if it is appropriate for a larger study. This study plan is looking at whether the use of inhaled sedatives (medications that help people be calm and sleep) can reduce delirium (extreme confusion) in children who need a ventilator (breathing machine) compared to IV or oral sedatives. The main question\[s\] it aims to answer are: * Will people join the study? (recruitment) * Will participants finish the study? * Will healthcare teams accept the study procedures? Participants will be randomized to receive study treatment (inhaled sedation) or standard of care (IV sedation). They will be monitored daily for up to 28 days. They will complete memory, thinking and behaviour tasks after 9-12 months.

This research aims to find out if giving plasma from a donor who recently had Chikungunya infection to newborns whose mothers have peripartum Chikungunya infection can improve the chances of newborns surviving without brain inflammation or damage within the first five days of life. The study will compare these results with a group of newborns who did not receive plasma transfusion due to delays in diagnosis or transfer, or parental refusal. The trial is led by the Centre Hospitalier Universitaire de la Réunion and includes newborns up to 2 days old. Participants in the treatment group will receive a plasma transfusion from donors who declared Chikungunya infection less than six months ago. This treatment is given to newborns whose mothers were diagnosed with Chikungunya infection around the time of birth. Newborns will be treated within 12 hours of birth or diagnosis depending on timing. There is also a parallel observational group of newborns who will not receive plasma but will be monitored as part of standard care. During the study, newborns will have daily medical and biological tests from day 1 to day 7, and a follow-up visit between 1 and 3 months of age. For the observational group, data collected during routine care up to 3 months will be used for research. Researchers will measure the effectiveness of early plasma administration in preventing neonatal brain inflammation or damage within five days after treatment. Safety and health will be monitored throughout the trial period, which is planned to end in late 2027.