Retinopathy of Prematurity

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 conducting a nationwide, multicenter observational study in China to investigate the severity and challenges faced by Small Vulnerable Newborns SVN, including preterm, small for gestational age, and low birth weight infants. The study aims to provide a clear and unified description of these newborns issues and to develop targeted prevention strategies to improve care and outcomes. This comprehensive research gathers data across multiple centers to better understand the scope of these conditions. In this study, participating hospitals across China will collect clinical data on vulnerable newborns under their care throughout 2024. Detailed questionnaires will be completed to support thorough data collection. The study does not involve any treatment interventions instead, it focuses on observation and data gathering to assess the incidence, complications, and mortality rates of these newborns. Participants in the study will have their clinical information recorded from hospital admission until discharge or death, with follow-up up to one year. Researchers will measure the number of small vulnerable newborns, their mortality rates, and the incidence of related complications. This observational approach aims to provide valuable insights to guide prevention efforts and improve care for these at-risk 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.

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.

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 Runion 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.

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.

Researchers are studying the effects of arginine supplementation on immune function in infants who have undergone major bowel surgery or have necrotising enterocolitis. This exploratory study will compare gene expression related to immune response in preterm and term infants receiving different nutrition regimens. The goal is to understand how arginine affects genes involved in nutrition and infection in postoperative babies. The study involves 48 infants divided into three groups one receiving standard parenteral nutrition without added arginine, one receiving parenteral nutrition with added arginine plus oral arginine supplementation, and one receiving standard parenteral nutrition with oral arginine supplementation only. Arginine dosing will begin with the first enteral feeds and adjust based on feeding progress. Treatment lasts up to 30 days post-surgery or diagnosis. Participants will have blood samples collected at specified intervals up to 30 days after surgery to analyze gene expression, amino acid levels, ammonia, and metabolomics. Routine nutritional intake and clinical lab data will also be recorded. Researchers will assess changes in immune-related gene activity, metabolomic profiles, and growth during the study period. The study is conducted across two neonatal centers under a neonatal partnership.

Phacoemulsification is a common cataract surgery performed under topical anesthesia, which is generally safe but can cause pain, anxiety, and discomfort for some patients. This research evaluates the effect of oral anti-anxiety medication, specifically Alprazolam, on improving patient satisfaction during second eye cataract surgery. The study aims to clarify whether oral sedation can reduce pain, anxiety, and side effects like nausea and dizziness compared to no sedation during phacoemulsification. Patients will receive either a single oral dose of Alprazolam or a placebo tablet 30 minutes before surgery. The dose of Alprazolam is 0.5 mg for most patients, with a reduced 0.25 mg dose for those over 65 years or with liver disease. The study compares these groups to assess how oral sedation affects anxiety, pain, and surgical satisfaction. This is an extension study involving patients undergoing surgery on their second eye with topical anesthesia. During the trial, participants will complete questionnaires assessing pain, anxiety, and overall satisfaction before and after surgery. Researchers will monitor intraoperative discomfort and postoperative anxiety levels. Data from approximately 250 patients will be collected and analyzed for these outcomes. This study runs from March 2025 to December 2027, focusing on improving cataract surgery experiences safely and conveniently.

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.

Researchers are conducting a phase 2 randomized trial to study the safety, effectiveness, and best dose of intravenous anakinra in extremely premature infants born between 24 and 28 weeks of gestation. This trial builds on earlier research showing that inflammation, especially involving interleukin-1, plays a key role in complications of prematurity. The goal is to find optimal dosing and assess an alternative subcutaneous route while monitoring drug behavior and early effects on inflammation and health outcomes. The study includes 24 infants randomly assigned to one of three dosing groups, each receiving anakinra intravenously for 21 days or intravenously for 14 days followed by subcutaneous administration for 7 days. The trial aims to develop models of how the drug is cleared, distributed, and absorbed in these neonates to guide future dosing. Participants will also receive standard care throughout the study. During the 3-week treatment, researchers will monitor drug levels and model pharmacokinetics and pharmacodynamics, including biomarkers of inflammation and clinical outcomes like lung and brain health. Safety will be followed closely up to 4 weeks, with additional neurological and respiratory assessments at 4 to 6 months. The trial will help determine the best dose and route of anakinra administration for very premature infants.