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 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 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 infant's 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 infant's 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.

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.

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 infant's 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.

Researchers are conducting an observational study to collect data on preterm babies with retinopathy of prematurity (ROP) who are treated with aflibercept (Eylea) delivered using a paediatric dosing device (PDD). ROP affects the eyes of preterm infants, especially those born before 32 weeks or weighing less than 1.5 kilograms, potentially leading to vision problems. The study aims to find out how many babies in the UK receive this treatment and to describe their characteristics and ROP symptoms. The treatment being studied is aflibercept, a drug injected into the eye to block abnormal blood vessel growth caused by ROP. It is given using a prefilled syringe combined with a paediatric dosing device to ensure safe and accurate dosing. The study collects data from babies treated with this method recorded in the National Neonatal Research Database from March 2024 to March 2025, or until April 2027 if more data is needed. Participants are not required to attend any visits or undergo tests for this study since only existing data from the database is used. Researchers will measure the number of babies treated with aflibercept using the PDD and summarize their characteristics, maternal factors, comorbidities, clinical conditions, resource use, outcomes, and ocular treatment details. The study will review data for up to three years following the drug's market introduction in the UK.

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 Fick's 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 Fick's 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 studying the use of Cereset Research (CR), a device-based intervention, to improve autonomic cardiovascular regulation in people aged 11 and older who have symptoms of stress, anxiety, or insomnia. This exploratory, open-label study aims to assess how CR affects heart rate variability, baroreflex sensitivity, and blood pressure variability. Secondary goals include evaluating changes in self-reported symptoms such as insomnia, depression, anxiety, and stress, along with exploring impacts in subgroups with other conditions like traumatic brain injury or PTSD. Participants will receive between 4 and 12 sessions of CR, which delivers audible tones echoing brainwave activity through sensors placed on the scalp with eyes closed. The device uses a 64-bit processing system and switches between sensor pairs during sessions to reduce interruptions and session length. This single-arm trial does not use a control group, and participants continue their usual care throughout the study. Participants will be evaluated at enrollment and through follow-up visits up to 4 to 6 weeks after the final session. Assessments include physiological measures such as blood pressure and heart rate variability, plus questionnaires on sleep, mood, anxiety, stress, traumatic stress, and quality of life. Data will be analyzed to measure changes from baseline and to explore effects in participants with coexisting symptoms or conditions. The total study duration for each participant varies depending on the number of sessions and follow-up timing.

Researchers are investigating the effects of Non-invasive Neurally Adjusted Ventilatory Assist (NIV-NAVA) on both short-term clinical outcomes and long-term neurodevelopment in very preterm infants. This observational study focuses on infants born between 27 weeks 0 days and 31 weeks 6 days of gestation who need respiratory support shortly after birth. The goal is to understand how NIV-NAVA impacts their health and development during their stay in neonatal intensive care and beyond. The study involves initiating respiratory support using NIV-NAVA within 48 hours after birth. The respiratory settings are tailored to each infant's condition, with options to switch to nasal continuous airway pressure or high flow nasal cannula as needed. For infants with respiratory distress syndrome, lung surfactant is given using a less invasive method to avoid intubation when possible. If intubation is necessary, early extubation to NIV-NAVA is encouraged, but invasive ventilation may be used if the infant's condition worsens. Participants will be closely monitored throughout their hospital stay, which can last up to three months in the neonatal intensive care unit. Researchers will track the rate of NIV-NAVA failure and various respiratory and neurological outcomes, including bronchopulmonary dysplasia, brain hemorrhages, and lung complications. They will also perform brain MRI scans and follow neurodevelopmental progress using standardized developmental assessments up to three years of age.

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 guideline's 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.