Neonatal Jaundice

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 studying infants with cholestasis, including conditions like biliary atresia and idiopathic neonatal hepatitis that cause prolonged jaundice and high bilirubin levels after the newborn period. The Childhood Liver Disease Research Network (ChiLDReN) aims to create a database of clinical information and biological samples from affected children to support research and clinical trials on these serious liver diseases in children. This project collects detailed clinical data, laboratory results, and biological samples such as blood and tissue from infants diagnosed or suspected to have biliary atresia or other neonatal liver diseases. Infants diagnosed with biliary atresia are followed closely during their first year, at 18 months, annually up to age 10, and then every two years, or until liver transplantation occurs. Infants with other cholestatic diagnoses exit the study after diagnosis is confirmed. Participants undergo routine clinical care and evaluations, with data entered into a secure national research database. Blood samples are collected during clinically indicated procedures when possible. Researchers measure disease progression over time at multiple intervals from baseline through 20 years of age. The study involves long-term follow-up of outcomes and data are securely stored and eventually transferred to a national data repository.

Researchers are evaluating the safety and effectiveness of a liposomal mitoxantrone combination regimen in treating relapsed and refractory solid tumors in children, adolescents, and young adults aged 6 to 24 years. This prospective, single-arm, multicenter clinical study aims to improve the objective response rate compared to historical data and to assess related side effects. The study focuses on specific tumor types including bone and soft tissue tumors and neuroblastoma among others. Participants will receive a treatment regimen combining mitoxantrone liposome, capecitabine, and anlotinib over 4 to 6 cycles, each lasting 21 days. Capecitabine is given twice daily on days 1 to 14, while anlotinib dosage is adjusted based on body weight and administered for 14 days per cycle. Those showing partial response or better may receive additional local treatments such as surgery or radiotherapy. During the study, participants will have regular checkups and tests to monitor tumor status, blood parameters, and other relevant health indicators. The main measurement is the objective response rate after up to 6 treatment cycles. Other outcomes include disease control rate, progression-free survival, overall survival, and safety monitoring for up to one year after treatment. The total observation period includes follow-up assessments to evaluate lasting effects and adverse events.

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.

Researchers are evaluating nipocalimab to reduce the risk of fetal anemia in pregnant individuals at risk for severe hemolytic disease of the fetus and newborn (HDFN). This condition involves a decrease in the baby's red blood cell volume during pregnancy. The study is a Phase 3 randomized, placebo-controlled trial aiming to compare nipocalimab's effectiveness to placebo in protecting live neonates from complications related to HDFN. Participants will receive either nipocalimab or a placebo through weekly intravenous infusions starting from randomization until gestational week 35. The study is double-blind and multicenter, ensuring that neither participants nor researchers know which treatment is given. The trial monitors pregnancies from early gestation through delivery and the neonatal period. Participants will be closely followed with assessments during pregnancy and after birth including monitoring for fetal loss, intrauterine transfusions, hydrops fetalis, neonatal death, and other health outcomes up to 104 weeks for the infant. The study also collects data on maternal health, pregnancy complications, infant development, and quality of life. Safety evaluations continue through 24 weeks postpartum, with detailed tracking of treatment effects and infant well-being.

Researchers are studying the risk of anemia in babies before and just after birth whose mothers are at risk for hemolytic disease of the fetus and newborn (HDFN). HDFN happens when the blood types of the pregnant participant and baby do not match, causing the baby's red blood cells to break down quickly. This non-interventional study aims to better understand this risk by following pregnant participants with HDFN risk and their babies over time. Pregnant participants who are at risk for HDFN during their current pregnancy will be enrolled and receive standard medical care according to their local practice. The study does not provide any treatment but collects data throughout pregnancy and for two years after birth from medical records and participant-reported outcomes. Data collection will occur at medical centers experienced in diagnosing and treating HDFN. Participants will provide medical information during pregnancy and after birth, including clinical outcomes and questionnaires about health status. Researchers will measure the percentage of pregnancies without fetal loss, intrauterine transfusions, hydrops fetalis, or neonatal death up to four weeks after birth. They will also track the severity of HDFN, timing of complications, and transfusions received. The study follows participants from conception through two years after delivery to gather long-term data.

Researchers are investigating treatments for children aged 1 to 18 years with chronic kidney disease (CKD) and proteinuria, conditions where the kidneys do not function properly and leak protein into the urine. CKD can cause complications like high blood pressure, and treatments currently include ACE inhibitors (ACEI) or angiotensin receptor blockers (ARB) that help control blood pressure and protein levels. This study focuses on evaluating the safety and effects of adding finerenone to these standard treatments, aiming to better manage the overactive kidney system involved in these conditions. Participants will receive finerenone orally, adjusted by age and body weight, alongside their existing ACEI or ARB treatment. The study lasts about 19 months, with up to 18 months of finerenone treatment and a one-month follow-up. During this time, children who are new to finerenone will have at least 12 visits, while those already on finerenone will have at least 8 visits. At these visits, various health checks and sample collections will occur to monitor safety and kidney function. Throughout the study, researchers will regularly measure blood pressure, heart rate, temperature, height, and weight, and collect blood and urine samples to assess kidney function and protein levels. They will also perform heart tests using electrocardiograms and echocardiography. Participants and their guardians will answer questions about medication use and any medical problems experienced. Safety will be closely monitored by tracking any adverse events during the study and a health check will be done about 30 days after treatment ends.

Researchers are evaluating the safety and feasibility of lung transplants from blood group A2 donors to blood group O recipients. This study aims to increase the donor pool for blood group O lung transplant candidates, who often face longer wait times and higher mortality on the waitlist. It is the first prospective study worldwide to assess ABO-incompatible lung transplants in this way. The intervention involves lung transplant surgery using lungs from blood group A2 donors transplanted into blood group O recipients who have low anti-A antibody levels and a negative virtual crossmatch at the time of transplant. The study monitors the recipients closely after surgery to assess immune response and transplant success. Participants will be monitored through various evaluations including antibody levels on post-operative days 5 or 12, primary graft dysfunction grading in the first three days, and assessment for rejection or infection over the following years. Long-term follow-up up to 10 years will evaluate graft function, chronic lung problems, infections, malignancies, and survival outcomes. The total participation time varies depending on individual follow-up and outcomes.

This research aims to evaluate the potential benefits of acupuncture as a treatment for children aged 6 to 12 years with Attention Deficit Hyperactivity Disorder (ADHD). It compares acupuncture combined with traditional Chinese herbal treatment to herbal treatment alone, using a mixed-methods approach that includes data mining, treatment outcome assessments, and patient perspectives. The study seeks to provide a detailed understanding of acupuncture's role in managing ADHD symptoms, executive function, quality of life, and sleep quality. Participants will be assigned to either an experimental group receiving acupuncture alongside herbal medicine or a control group receiving only the herbal treatment based on Chinese Medicine clinical guidelines. Acupuncture treatments involve specific needles and techniques informed by prior data analysis of effective acupoints for ADHD. Herbal treatments follow established clinical guidelines for pediatric ADHD. The study includes three phases: acupoint data mining, clinical intervention with repeated assessments, and qualitative interviews with children, caregivers, and clinicians. During the 12-month study, children will undergo quantitative assessments such as the SNAP-IV, Conners 3-P, BRIEF-2, PedsQL 4.0, PSQI, and CGI at baseline, post-treatment, and follow-up points to measure ADHD symptoms and related impacts. Qualitative interviews will explore treatment experiences and satisfaction. Researchers will analyze changes in symptoms, executive function, quality of life, and sleep, combining statistical methods with thematic analysis. The study starts in October 2024 and is expected to complete by May 2026.