Patent Ductus Arteriosus

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 infants 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 investigating the use of bubble continuous positive airway pressure bCPAP in preterm infants born before 32 weeks gestation. This observational, proof-of-concept study aims to understand how the sounds produced by the bubbling in the bCPAP device relate to the airway pressures delivered to the infants lungs. The goal is to develop models that predict these pressures from the acoustic properties of the bubbling sounds, potentially offering a new way to monitor therapy effectiveness in real time. The study involves two groups of 15 preterm infants each, all receiving bCPAP treatment in the neonatal intensive care unit. Group 1 will have their external bubble sounds and CPAP system pressures recorded using a microphone on the water tank and a pressure transducer in the expiratory limb for 3 hours. Group 2 will have similar measurements plus internal sounds and pressures recorded via a wireless sensor placed on the infants suprasternal notch and an internal pressure transducer inserted into the nasopharynx, also for 3 hours. During the study, participants will be monitored for 3 hours with continuous recording of pressures and acoustic data. Researchers will assess external and internal bubble sounds alongside airway pressures. Data collection uses specialized devices to capture and store sound and pressure information for later analysis. The study helps evaluate the relationship between acoustic signals and pressure delivery in preterm infants on bCPAP, with the entire study expected to run until December 2026.

Researchers are conducting a pilot study to evaluate if inhaled sedatives can reduce delirium, a state of extreme confusion, in children on mechanical ventilators compared to the usual intravenous IV sedatives. This study aims to assess the feasibility of the study plan, including recruitment, participant completion, and healthcare team acceptance. The trial focuses on pediatric patients who require sedation for mechanical ventilation and is designed as a randomized controlled trial. Participants will be randomly assigned to receive either inhaled sedation with Isoflurane delivered through an inhalation device or standard IV sedation provided by hospital care. Dosages for both sedatives will be adjusted by the healthcare team to best support the participants treatment needs. Participants will be monitored daily for up to 28 days during their ventilation period. Throughout the study, participants will undergo assessments of memory, thinking, and behavior 9 to 12 months after treatment. Researchers will also track recruitment rates, adherence to the study protocol, participant dropout rates over three years, safety and adverse events for up to 13 months, and healthcare team satisfaction in the first three days. The study is expected to complete by December 2026.

Researchers are studying preterm infants born between 25 and 32 weeks of gestation to compare two methods of incubator temperature control and their effects on infant weight growth and health. The study is based on earlier findings that lower body temperature on admission relates to higher illness and death rates in preterm infants. It aims to see if using a new software to calculate personalized air temperature in incubators can improve growth and reduce side effects compared to the traditional skin temperature control method. The study compares two incubator control methods air temperature control ATC, which uses software to set air temperature to reduce body heat loss to zero, and skin servocontrol SSC, which adjusts incubator temperature based on the infants skin temperature. Both methods are evaluated in closed incubators for preterm infants. The trial randomly assigns infants to one of these two methods to study their effects during the first 10 days of life. Participants will be monitored for changes in body weight until day 10, along with comfort, thermal stress, and humidity challenges. The study also tracks neonatal illness occurrences up to 40 weeks of amenorrhea and length of hospital stay until discharge or 40 weeks of amenorrhea. Parents provide written consent, and infants are included within the first day of life. The study continues through hospitalization, assessing health outcomes and safety related to the incubator settings.

This observational study collects data from preterm babies with retinopathy of prematurity ROP who are treated with aflibercept Eylea using a paediatric dosing device PDD. ROP affects the retina in premature infants, especially those born before 32 weeks gestation or weighing less than 1.5 kilograms, and may lead to vision problems or blindness if untreated. The study aims to understand how many babies in the UK receive aflibercept with this dosing device and to evaluate if this number is sufficient for future safety studies. Participants are preterm infants diagnosed with ROP who receive aflibercept 0.4 mg via an Eylea prefilled syringe combined with the PICLEO paediatric dosing device. This drug blocks abnormal blood vessel growth in the retina by targeting vascular endothelial growth factor VEGF. Data are collected from the National Neonatal Research Database covering babies born from March 2024 to March 2025 or until April 2027 if more data are needed. Since this is an observational study, no additional visits or tests are required beyond routine care. Researchers will review existing data on participant characteristics such as age, sex, race, maternal factors, clinical conditions, and treatment outcomes. The main outcome measures include the number of babies treated with aflibercept using the PDD and summaries of their clinical and ocular conditions over up to three years after market introduction.

Cardiac output measurement is an important hemodynamic parameter frequently used in pediatric intensive care units ICUs. This trial aims to evaluate the feasibility of measuring cardiac output using Ficks method, a non-invasive technique that allows continuous monitoring, compared to the standard echocardiography method which is operator-dependent and cannot provide continuous data. The study is sponsored by University Hospital, Montpellier, and focuses on pediatric ICU patients under 18 years old. The study involves two diagnostic tests cardiac output measurement by Ficks method using a metabolic monitor and measurement by echocardiography. Patients under 18 admitted to the pediatric ICU who meet specific criteria will be monitored using both methods. This comparison will assess the correlation between the two measures up to day 3 of monitoring. Participants will be monitored for cardiac output variations before and after a Leg Raise Test, and adverse events will be recorded on catheterization and catheter removal days, up to 21 days. The primary outcome is the agreement between cardiac output measurements by both methods within the first three days. The total participation involves close monitoring and safety assessments during their ICU stay until study completion in 2025.

Researchers are evaluating Cereset Research CR, a device-based intervention, to improve autonomic cardiovascular regulation in people aged 11 and older who experience symptoms of stress, anxiety, or insomnia. This open-label exploratory study aims to assess how CR affects heart rate variability, baroreflex sensitivity, and blood pressure variability. Secondary and tertiary objectives include examining changes in self-reported symptoms of insomnia, depression, anxiety, stress, and other related conditions, as well as exploring effects in specific subgroups with co-existing medical issues like PTSD, chronic pain, or prior stroke. Participants will receive between 4 and 12 sessions of CR, which uses audible tones echoing brainwave activity to provide real-time feedback. The intervention involves wearing sensors on the scalp while sitting comfortably with eyes closed. The upgraded CR system includes faster processing and fewer interruptions during sessions. Participants will continue their usual care throughout the study. Data collection will occur before and after the intervention, including physiological measures and symptom questionnaires. During the study, participants will attend an enrollment visit for baseline assessments, followed by the intervention period starting within 14 days. Follow-up assessments will take place 4 to 6 weeks after the final session to measure changes in autonomic function and symptoms. Researchers will also collect additional data on quality of life and specific condition-related outcomes. The study will monitor safety and gather information on medication effects, barriers to treatment, and participant experiences. Total participation duration varies based on the number of sessions received and follow-up timing.

This observational study examines the effects of Non-invasive Neurally Adjusted Ventilatory Assist NIV-NAVA on very preterm infants born between 27 weeks 0 days and 31 weeks 6 days of gestation. The research aims to understand how NIV-NAVA influences short-term clinical outcomes and long-term brain development in these infants who need respiratory support shortly after birth. Participants will receive respiratory assistance starting within 48 hours of birth using NIV-NAVA. The respiratory settings will be tailored to each infants condition and may change to other forms of support like nasal continuous airway pressure or high flow nasal cannula, or stop after initial stabilization. If infants develop respiratory distress syndrome, lung surfactant will be given using a less invasive method, and invasive ventilation may be used if necessary. During the study, infants will be closely monitored for respiratory outcomes, including failure rates of NIV-NAVA and duration of ventilation. Researchers will also assess complications like bronchopulmonary dysplasia, brain injuries, and retinopathy. Brain imaging at term-equivalent age and developmental assessments up to 3 years will evaluate neurodevelopmental progress. The study follows infants through their hospital stay up to three months and includes long-term developmental follow-up.

Researchers are studying the treatment of patent ductus arteriosus PDA, a common heart complication in extremely premature infants born before 27 weeks gestation. The study aims to compare the effects, safety, and clinical outcomes of a combination therapy using ibuprofen plus intravenous acetaminophen versus ibuprofen alone, the current standard treatment. This Phase 2 trial also evaluates neurodevelopmental outcomes at 18 to 30 months corrected age to understand the long-term impact of the treatments. Participants will receive either standard ibuprofen dosing, given intravenously or enterally and adjusted by age, combined with intravenous acetaminophen administered every six hours for three days, or standard ibuprofen with a placebo saline injection on the same schedule. The dosing of ibuprofen typically involves a higher initial dose on day one, followed by lower daily doses on days two and three. The study is randomized and triple-blinded to compare these two groups effectively. During the trial, infants will be closely monitored for outcomes such as mortality before discharge, bronchopulmonary dysplasia severity, treatment success, kidney and liver function, and the need for further PDA treatment or procedures. Researchers will also track respiratory support duration, use of medications like diuretics and steroids, incidence of sepsis, and other complications up to 250 days after randomization. The trial spans from initial treatment through hospital discharge or transfer, with long-term neurodevelopmental assessments planned.

Premature infants in neonatal intensive care units NICUs face challenges due to their immature physiology and sensitivity to environmental factors. This research aims to develop and assess a clustered care practice guideline based on individualized developmental care principles to minimize the negative impact of routine care and support infants physiological stability. The study is a single-blind randomized controlled trial involving nurses in NICUs to evaluate how clustered care affects nursing practices. The study involves two groups of nurses an intervention group receiving training on clustered care guidelines tailored to individualized developmental care and a control group continuing standard care practices. The training consists of two in-person sessions lasting about 45 minutes each, with small group sizes and a training booklet. After training, nurses in the control group will also receive the same training once the study concludes. Nurses behavior changes will be assessed within six weeks after training, along with their opinions on the guidelines effectiveness gathered 4-6 weeks post-intervention. Data collection includes pre- and post-training assessments using descriptive forms and the clustered care guideline. Ethical approval and informed consent from nurses and infant parents have been obtained, ensuring careful monitoring and evaluation throughout the study period from July to September 2025.