Clinical trials

Overall, our understanding of how pain and sleep are experienced and how they can be treated in teenagers with rheumatic diseases is limited. This two-phased study aims to deepen our understanding of pain and sleep in this population using 'Better Nights, Better Days for Youth' (BNBD-Youth). 'BNBD-Youth' is a self-guided web-based sleep program for teenagers with sleep problems that uses educational and behavioural strategies, such as understanding sleep processes and changing unhelpful thoughts about sleep, to help improve sleep experiences. In Phase One, participants will use daily diaries to record their sleep and pain, and then use 'BNBDYouth' for five weeks to test whether it improves these outcomes. Then, in Phase Two, these participants will take part in an interview to further describe their experiences using 'BNBD-Youth' and their pain and sleep.

The goal of this observational study is to improve the way newborn babies are cared for before, during, and after major surgery. Surgery can be very stressful on a baby's body. This study looks at whether a structured care plan called Neonatal Enhanced Recovery After Surgery (nERAS) can help reduce complications and improve recovery. This study has three main goals: 1. To evaluate whether the nERAS guidelines improve short-term health outcomes for newborns who need major surgery, 2. To understand how well the guidelines are adopted and followed by healthcare teams, 3. To study longer-term development outcomes (up to 18 months after surgery) for a group of babies treated under this care pathway. Researchers will compare babies who received standard surgical care before nERAS was introduced with babies who received care after nERAS was implemented with a multifaceted implementation strategy. This will help determine whether the guidelines improve recovery and overall outcomes. The study involves reviewing medical records of newborns who had surgery. In addition, healthcare providers and parents or caregivers may be asked to complete surveys or participate in interviews or focus groups to share their experiences with this care approach.

This study aims to understand how the TEACH program helps improve mental health and well-being in adolescents with childhood-onset lupus. Researchers will examine changes in brain function and inflammation before and after the program and explore how these changes relate to improvements in symptoms such as anxiety, depression, fatigue, and pain. Twenty adolescents with cSLE, aged 12-18 years, will participate by completing the TEACH program, brain imaging, blood tests, and questionnaires.

Children with medical complexity require intense caregiving from their parents and other health care providers, such as family doctors and medical specialists. These children have complex and lifelong medical conditions, and can be dependent on technology to help them breathe, move, or eat. From a young age, siblings of children with medical complexity typically assume caregiving roles to support their families. Caregiving may be associated with increased depression and anxiety in siblings, disruptions in routine, parental neglect, and constant changes. There is a gap in research on, and supports for, the mental health of these siblings. The goal of this study is to understand how to best support the mental health of siblings of children with medical complexity. A new model of support that involves measuring mental health symptoms in siblings age 10-17 through surveys and a mental health assessment conducted by social workers was created. Siblings who need support can be referred to social work and child psychiatry services that are integrated in the health care team the family already has a relationship with. By using screening and built-in supports, the investigators hope to create a pathway for siblings that is easy to access and proactive. Social workers can provide talk therapy to help siblings manage difficult emotions. Psychiatrists can provide a medical diagnosis if the sibling meets the criteria for an illness such as depression or anxiety. Psychiatrists can also recommend medications or resources to help siblings manage symptoms. This is a pilot study, meaning the investigators are exploring a new model and would like to gather more information on whether it is realistic to run this model, whether siblings will use it, and to gather information on sibling mental health patterns. The investigators will also be interviewing siblings so they can share their experiences with caregiving and any challenges with mental health support. Findings from this study can inform a larger, more robust study to measure how effective the model is compared to normal care. While sibling research is new, the investigators have already conducted a similar study where this model was tested on parents of children with medical complexity. The investigators found parents used the model and were linked to supports quickly.

This study will compare two commonly used ureteral stents in children and adolescents undergoing staged treatment for kidney stones. Ureteral stents are small tubes placed between the kidney and bladder to help urine drain after a procedure. Although stents are effective, they can cause bladder spasms, pain, urinary urgency, and other uncomfortable symptoms. Participants aged 8 to 18 years will receive both a standard Cook double-J ureteral stent and a Polaris Ultra ureteral stent during two planned procedures. The order in which the stents are used will be assigned at random, and participants and caregivers will not be told which stent is in place during each treatment period. Participants will report bladder spasms, pain, urinary symptoms, and quality of life through questionnaires and symptom assessments. The study will determine whether differences in stent design affect comfort, bladder spasms, urinary tract infections, or other stent-related complications. Both stents are approved by Health Canada and are used as part of routine clinical care.

Families of children with arthritis are highly interested in the benefits of diet to improve their child's disease and future health outcomes. Previous research shows that the germs - bacteria and other organisms - that live in the intestines (gut microbiome) are important to how well immune systems work, and that what people eat changes their gut microbiome. The investigators want to study whether a certain diet - based on the principles of the Mediterranean Diet - will improve arthritis for children and whether it was changes in the microbiome that led to improvement. Fifty-four participants in this study will change their diet for an 8-week period, and will have the option of remaining on the diet for an additional 4 weeks. At three time points during the study (beginning, 8 weeks, and 12 weeks), participants will provide stool and blood samples, will complete questionnaires about diet and other aspects of lifestyle and health, and will complete a disease assessment by a clinician. From collecting all these samples and information, the investigators will be able to determine if the diet was successful in improving disease activity in children with arthritis and if the gut microbiome was changed as well. This study will help the investigators figure out if a larger, and more definitive, study like this is possible to do in children with arthritis and will help the investigators design a bigger multinational study to confirm how diet affects disease outcomes and the microbiome in children with arthritis. If successful, this research will provide scientific knowledge to help families make their way through this difficult to- navigate topic.

SickKids and UHN have developed MedlyPeds which is a smart phone application designed to remotely monitor patients with heart disease. This is a feasibility study which will enroll up to 30 patients with different types of heart disease to see which patient types may benefit the most from MedlyPeds if it were to be used for clinical monitoring. The study is gathering feedback about the app from patients, parents and clinicians to confirm how it needs to be modified to better serve the purpose in a future trial.

We propose a multicenter prospective study on pediatric patients with intestinal failure (IF) who weaned off parenteral nutrition (PN).

This study is looking at two different treatments for obstructive sleep apnea (OSA) in children. OSA is a sleep condition where breathing repeatedly stops and starts during sleep, which can affect a child's health, behavior, learning, and quality of life. Children with moderate-to-severe OSA who cannot be treated with surgery are often prescribed Continuous Positive Airway Pressure (CPAP). CPAP uses a mask worn during sleep to deliver pressurized air and keep the airway open. Although CPAP is effective, many children have difficulty using it regularly because it can feel uncomfortable or hard to tolerate. This study compares CPAP with another treatment called High-Flow Nasal Cannula (HFNC). HFNC delivers warm, humidified air through soft nasal prongs and may be more comfortable and easier for children to use while still helping keep the airway open during sleep. Children aged 2 to 18 years with moderate-to-severe OSA will be randomly assigned to use either CPAP or HFNC at home during sleep for 3 months. The study will measure how much each treatment is used, how well it improves sleep-related symptoms and quality of life, how comfortable it is for children, and how it affects caregivers. The goal of this study is to find out whether HFNC is a comfortable and effective alternative to CPAP for treating obstructive sleep apnea in children.

Hydronephrosis is a common congenital kidney anomaly. While most cases resolve on their own, some require surgery. Clinicians rely on repeated ultrasounds and sometimes invasive tests to decide if surgery is needed, but predicting outcomes is difficult. Researchers at SickKids developed an AI model that analyzes ultrasound images to assist in diagnosing and managing hydronephrosis. This study tests how well the AI integrates into real-world care. Clinicians will first make care decisions without AI and then review the AI's prediction before deciding whether to change their plan. A separate expert, unaware of whether AI influenced the first clinician's plan, will make the final decision to ensure care remains unchanged. The study will assess whether AI improves decision-making, reduces unnecessary tests, and fits into clinical workflows. If successful, the AI model could serve as a complementary tool to make diagnoses more efficient and precise while minimizing invasive procedures.

Children with medical complexity (CMC) often have trouble breathing at night and need to use a breathing machine. This breathing machine is called noninvasive positive pressure ventilation (NiPPV). The use of NiPPV has been shown to improve quality of life and survival in children. Before it is used, NiPPV must first be tested to see what the correct 'machine settings' are for each child. This is usually done in the sleep laboratory at the hospital during a one-night stay. However, sleep studies in the hospital are disruptive and hard for CMC and their families because of the new environment and limited access to the equipment, supplies, comfort items and the routine their child has at home. Patients and families would prefer to start NiPPV at home but there needs to be more research on this to make sure it is possible and safe. This study will evaluate a new model of care to start NiPPV in the home. CMC aged 5-17 years old and starting NiPPV will be assigned at random, like a coin toss, to start NiPPV in the home or to start NiPPV in the sleep laboratory. The investigators will assess the feasibility and safety of the two ways to start NiPPV. This study will be the first step towards developing a study to evaluate if home NiPPV starts are effective. Starting NiPPV at home has the potential to improve the use of NiPPV (ie early adherence predicts long-term use) resulting in both medical benefits as well as improved quality of life for CMC and their families.

The purpose of this study is to evaluate the safety and explore the PK/PD of L-CIT supplementation in preterm infants to prevent the development of inflammatory pathways initiated by low levels of plasma CIT, specifically in preterm infants with post-surgical NEC and BPD±PH.

The goal of this trial is to determine the effectiveness of a machine-learning (ML) model predicting a serious cardiac event within the next three months, when compared pre- versus post-deployment, in pediatric cardiac inpatients. The main questions it aims to answer are whether deployment of the ML model: 1. Increases PACT consultation within the next three months among admissions without PACT involvement in the previous 100 days 2. Increases PACT consultation or visit within the next three months among those who experience a serious cardiac event during this period 3. Decreases time to PACT consultation or visit among those seen by PACT during this period 4. Decreases the incidence of death in the intensive care unit (ICU) 5. Increases documentation of goals of care High-risk cardiology patients will be identified by an ML model each morning. If the patient has been seen by the PACT team within the past year, the update will go to the PACT team members. If the patient hasn't been seen by the PACT team, the email will be sent to the cardiology physician in charge of the patient. This physician will decide whether a PACT consultation is necessary based on their clinical judgment. If so, a referral will be made using the usual process. Outcomes of the identified patients will be compared pre- and post-deployment.

This is a Prospective Observational study. The aim of the study is to understand the underlying photoreceptor, retinal pigment epithelium or retinal vascular aberrations in inherited and acquired retinal disorders. The study would use adaptive optics (AO) technology to assist in-vivo visualization of these retinal structures and ascertain changes from normal. Further, by using the AO imaging in patients before and after treatments, this study aims to better understand the effect of various interventions and develop AO as an outcome measure in various retinal disorders.

This study will evaluate a virtual mental health parenting stepped-care intervention (I-InTERACT-North) to determine if the program works to improve positive parenting skills and child behaviour among families with children born with Congenital Heart Disease (CHD). Recruitment will target children ages 3-9 years old from SickKids. We will also evaluate the acceptability and feasibility of the program among children and families to inform future delivery and multi-site trials. Results will evaluate whether I-InTERACT-North can improve parenting and child behaviour in these families and inform future best clinical practices for this population.

We aim to determine whether pectoral nerve block (PECS) performed after induction of anesthesia but before surgical incision results less opioid use in the post operative period compared with local infiltration alone in children undergoing Cardiac Implantable Electronic Device (CIED) surgery.

The purpose of this study is to determine if the position of the anesthesia machine affects the ability of anesthesiologists to manage a crisis situation and perform critical tasks. Participants will be asked to manage a simulated crisis situation using a manikin in the operating room. The anesthesia machine will be positioned either in an "optimal" or "awkward" manner for the anesthesiologist. The session will be video recorded and then analysed for various outcomes that reflect the anesthesiologist's performance. Participants will also perform a critical task, bag-valve-mask ventilation, on a manikin with the anesthesia machine in the optimal and awkward positions. The effectiveness of ventilation in each position will be compared. The results of this study may have implications for patient safety.

This project will be conducted in 2 hospitals in Brazil to assess the requirements for four essential amino acids in TPN fed neonates. Using the Carbon Oxidation method (indicator amino oxidation and direct amino acid oxidation method), the investigators will determine the requirement of each of the 4 amino acids. The investigators will determine the requirement for Isoleucine, Leucine, Valine and Tryptophan. The investigators will recruit 18- 20 babies per amino acid study. Breath and urine samples will be collected to determine the oxidation of the indicator amino acid. The response of the indicator amino acid to changes in intake of the test amino acid (isoleucine, leucine, valine and tryptophan) will be analyzed by bi-phase linear mixed effect model to determine the breakpoint or mean requirement for each amino acid. It is hypothesized that the requirement for isoleucine, leucine, valine and tryptophan will be at least 50% lower than what is currently available in commercial solutions used for TPN feeding of neonates.

The goal of this observational study is to learn if magnetic resonance imaging guided focused ultrasound (MRgFUS) can treat brain lesions causing epilepsy in children with drug resistant epilepsy. The main questions it aims to answer are: Is MRgFUS safe in children with drug-resistant epilepsy due to central brain lesions? Does MRgFUS treatment reduce seizure frequency and severity and improve quality-of-life? Researchers will prospective assess outcomes following MRgFUS in children. Participants undergoing MRgFUS will complete seizure diaries and questionnaires related to seizure severity and quality-of-life.

Deep Brain Stimulation for the Treatment of Severe Refractory Self-Injurious Behaviour in Children with Autism Spectrum Disorder: A Randomized Trial To evaluate the effectiveness of deep brain stimulation (DBS) of the nucleus accumbens for the treatment of severe refractory, repetitive self-injurious behavior (SIB) in children with Autism Spectrum Disorder. Secondary objectives are to examine the effects of DBS on subtypes of SIB through functional analysis.

This study is being done to determine whether MRI can produce high quality lung and airway images in healthy and CF patients and if MRI can be used to evaluate size and shape of the airways with computer assistance. This study will also repeat MRI experiments two years after the initial MRI scan to see if changes to airway size and shape are seen over time. In a subset of participants, we will investigate whether MRI results are repeatable and reproducible in the short-term one week after the initial MRI visit. This study will help understand if MRI based measurements of airway size and shape can be used as a monitoring tool that does not use x-ray radiation in patients with CF.

The goal of this trial is to learn if a machine learning (ML) model can help optimize drug therapy in the pediatric population. The main question\[s\] it aims to answer are whether a machine learning model predicting receipt of a targeted medication within the next three months: * Increases the offering of pharmacogenetic testing prior to receipt of a targeted medication * Increases the number of patients with pharmacogenetic results prior to receipt of a targeted medication * Increases the number of patients who have alteration in medication choice or dose based on pharmacogenetic results This trial only focuses on the prediction and provision of participants with a high-risk of receiving a medication with a pharmacogenetic indication in the next three months.

The goal of this single arm trial is to learn if a machine learning (ML) model predicting the risk of vomiting within the next 96 hours will impact vomiting outcomes in inpatient cancer pediatric patients. The main questions it aims to answer are whether an ML model predicting the risk of vomiting within the next 96 hours will: Primary 1\. Reduce the proportion with any vomiting within the 96-hour window Secondary 1. Reduce the number of vomiting episodes 2. Increase the proportion receiving care pathway-consistent care 3. Impact on number of administrations and costs of antiemetic medications Newly admitted participants will have a ML model predict the risk of vomiting within the next 96 hours according to their medical admission information. The prediction will be made at 8:30 AM following admission. Pharmacists will be charged with bringing information about patients' vomiting risk to the attention of the medical team and implementing interventions.

The study examines whether a mechanical arm ultrasound system provides diagnostic accuracy comparable to expert-performed full ultrasound for detecting key joint components and whether it can reduce acquisition variability without compromising accuracy, as measured by false-positive and false-negative rates.

In this study, we will study 129Xe-MRI and LCI as tools for diagnosis of BOS in pediatric patients who have received Hematopoietic Stem Cell Transplantation (HSCT) and have been identified as eligible for this study. Participants will be required to have vital signs collected, complete breathing tests and complete an MRI. The MRI will require participants to perform breath holds in the MRI scanner with xenon gas while being coached by a research assistant.