Spina Bifida

Researchers are investigating the use of ABM/P-15 bone graft compared to traditional bone graft in patients undergoing surgery for Adult Spinal Deformity (ASD). This study aims to improve clinical outcomes by promoting faster bone healing, reducing the need for additional surgeries, minimizing complications, and improving health-related quality of life. The trial is a prospective, randomized, controlled clinical study conducted at a specialized spine unit. Participants are randomly assigned to receive either the ABM/P-15 bone graft, which is a device combining anorganic bovine bone mineral with a synthetic peptide to enhance bone growth, or a standard bone graft made from locally harvested bone mixed with morselized allogenic femoral head. Both graft types are used during posterior spinal instrumentation and fusion surgery, with anterior support added as needed. The ABM/P-15 bone graft is placed on the spine structures and contained by the surrounding muscle. The study includes preoperative planning, surgery, and follow-up evaluations up to two years. Participants complete questionnaires before surgery and at 3 months, 1 year, and 2 years after surgery. They undergo X-rays at multiple time points and a CT scan one year after surgery to assess bone fusion and detect pseudarthrosis. Researchers track revision surgeries, adverse events, and cost-effectiveness during the study. Data on surgical details, complications, medication use, and rehabilitation are collected from medical records. The total participation lasts about two years, allowing for detailed assessment of outcomes and safety.

This research aims to create a pediatric robotic spine surgery registry to collect and analyze data on the combined use of robotics and navigation, along with patient-specific rods, in surgeries for pediatric spine deformities. The study includes patients diagnosed with various spine deformities such as idiopathic scoliosis, adolescent idiopathic scoliosis, spondylolisthesis, congenital scoliosis, and neuromuscular scoliosis. The goal is to establish an educational and informative framework for this technology across participating institutions. Participants will undergo standard-of-care spine deformity surgery that uses robotics coupled with navigation and/or patient-specific rods. The study focuses on observing these surgeries without introducing experimental treatments. Data will be gathered during surgery and at follow-up intervals to assess surgical precision and outcomes. During the study, researchers will track the precision of pedicle screw placement within 2 mm of cortical breach during surgery. They will also measure radiation exposure to patients and surgeons, operative time, blood loss, and total operative cost. Participants will complete several questionnaires at baseline, 6 months, 1 year, 2 years, and 5 years to evaluate physical activity, emotional distress, pain interference, peer relationships, and quality of life. The study follows participants for up to five years to monitor improvements in spine alignment and other health outcomes.

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.

Spinal deformities are common conditions affecting both children and adults, needing precise spine alignment assessment for treatment planning. Researchers are evaluating an AI-powered system called AlignProCARE to assist doctors in diagnosing and analyzing these deformities more quickly and consistently. This study involves multiple centers across Malaysia, China, and Japan to improve the AI system's performance and accuracy. Participants will have whole spine X-rays and nude back photos taken at the start and during follow-up visits. The study aims to collect 500 labeled images per center and follow 150 patients over time to measure spinal parameters and update the AI system (AlignProCARE+) using new data. This process includes detailed analysis of spinal curvature and alignment. During the study, participants' spine measurements will be evaluated using X-rays and photos, focusing on outcomes like Cobb angle, thoracic kyphosis, lumbar lordosis, pelvic tilt, and curve severity over one year. The study uses routine care for spinal deformities and monitors participants' spinal changes through imaging and AI assessment, helping to validate and refine the AI tool for clinical use.

This research aims to develop and validate an artificial intelligence (AI) software to recognize fetal brain structures and distinguish between normal and abnormal brain anatomy during the second trimester ultrasound scan. The study focuses on fetal brain abnormalities, which are challenging to diagnose prenatally. AI technology may improve detection, reduce variability between operators, shorten examination time, and optimize healthcare resources. The study is conducted by multiple fetal medicine centers and targets pregnant women undergoing routine screening for fetal anomalies. The study consists of two phases: a retrospective phase and a prospective phase. In the first phase, researchers collect and analyze ultrasound images taken between 19 and 22 weeks of gestation from various centers to develop and train the AI algorithm with both normal and abnormal fetal brain images. The second phase prospectively tests the AI algorithm in real clinical settings on patients from the participating centers to validate its performance in assessing fetal brain anatomy. Participants are singleton pregnant women between 19 and 22 weeks of pregnancy who undergo ultrasound scans. Researchers will collect clinical, ultrasound, prenatal, and postnatal data, anonymize images, and store them securely for analysis. The primary outcome is validating the AI algorithm over two years. Secondary outcomes include improving reproducibility and reducing examination time within one year. The study involves continuous monitoring and assessment of ultrasound images to support routine fetal brain screening.

Researchers are evaluating the impact of using an autologous umbilical cord tissue patch for closing open neural tube defects in newborns diagnosed prenatally with conditions such as myelomeningocele or myeloschisis. The study aims to assess how well this patch repairs the defect, increases the spinal canal space, and reduces inflammatory tissue response compared to past treatments. This investigational procedure is sponsored by The University of Texas Health Science Center, Houston. The treatment involves harvesting umbilical cord tissue at birth and immediately processing it to create a dural patch that covers the spinal cord defect within a few hours after delivery. Surgery is performed within 24 hours of birth to close the developmental defect using this patch. This approach is being studied as a new surgical option for postnatal repair of open neural tube defects. Participants will be closely monitored after surgery for wound healing complications such as wound opening and cerebrospinal fluid leakage at one month and one year post-operation. Additional evaluations include tracking the development of tethered cord syndrome and changes in neurological function over a period extending to five years. The study requires signed consent and ongoing participation with several follow-up assessments to measure safety and efficacy outcomes.

Researchers are studying adults with spinal deformity to develop reliable methods for assessing trunk strength and overall functionality. The study aims to compare the functional ability of adults with spinal deformity to healthy controls and link these functions to the nature of their spinal deformity and muscle condition. This research also seeks to move from 2D to 3D dynamic models to better understand and improve clinical decisions in spinal deformity care, focusing on surgical outcomes like post-surgery shoulder balance. Participants include two groups: healthy volunteers and adults with spinal deformity. Both groups undergo a balance assessment scale and trunk strength measurements using electromyography (EMG). They also receive MRI scans of the spine and pelvis, along with EOS stereoradiographic full body exams. These diagnostic tests help capture detailed images and mechanical behavior of the spine. The study collects data at baseline and continues assessments up to two weeks to observe trunk muscle strength. During the study, participants will perform trunk strength tests in a sitting position using a handheld device, and their balance and posture will be evaluated through imaging and force plate measurements. Researchers will monitor trunk muscle strength from screening through week two and perform static 2D radiographic evaluations on the first day. The study involves no randomization or masking and includes adults aged 18 to 79 years. Safety, consent, and functional ability to walk certain distances independently are also assessed throughout the participation period.

Researchers are studying whether oral sucrose (sugar water containing 24% sucrose) can reduce pain and distress in infants undergoing flexible nasolaryngoscopy, a procedure used to examine the nasal and throat areas. This study takes place in an outpatient setting at the SickKids Pediatric Otolaryngology Clinic and aims to understand how sucrose affects pain scores and other measures in babies during this procedure. Participants will be randomly assigned to receive either sterile water without sugar (placebo) or sugar water with 24% sucrose before the nasolaryngoscopy. The sucrose solution is not classified as a drug by Health Canada. The study uses a quadruple masking method, meaning that participants, caregivers, and researchers do not know which solution is given. This helps compare the effects of the sugar water to sterile water more accurately. During the study visit, researchers will measure pain scores, crying time, heart rate, time to baseline, skin conductance, visit duration, and caregiver impressions in infants up to 7 months old. Caregivers provide consent, and infants are monitored closely during and after the procedure to assess these outcomes. The total participation spans the scheduled clinic appointment when the flexible nasolaryngoscopy is performed.

This research gathers data and biological samples from pregnant women to study prematurity, preeclampsia, and other pregnancy complications. It combines information from four original studies involving women at different stages of pregnancy, including those with low risk and those diagnosed with preeclampsia. The goal is to better understand early onset preeclampsia and related conditions using medical, social, obstetrical, and ultrasound data along with biological markers and genetics. Participants in the biobank provide blood and urine samples along with detailed clinical and demographic information. The studies include women pregnant with singletons or twins at various early gestational ages, some randomized to receive low-dose aspirin or placebo. Ultrasound examinations and blood pressure measurements are also part of the data collection, with access to medical records for pregnancy outcomes and newborn health. Women in the biobank undergo assessments including blood sample collection, urine testing, blood pressure monitoring, and ultrasound scans. Researchers use this information to measure outcomes such as early onset preeclampsia diagnosed between 20 and 34 weeks, severe preeclampsia, fetal growth restriction, spontaneous preterm birth, and fetal anomalies. The study started in 2015 and plans to continue until 2028, offering long-term follow-up of pregnancy complications and their outcomes.

Researchers are studying how different enema programs affect bowel control in children and adults with spina bifida, a rare condition that impacts the spinal cord and many body systems, including the bowels. The study focuses on comparing two types of enema programs to find out which one better prevents bowel accidents and improves quality of life, independence, and bowel symptoms. This observational study involves participants starting a new enema program and follows their progress over one year. The study compares retrograde enemas, given through the rectum, and antegrade enemas, given through a surgically created tube at the start of the colon. Participants receive their assigned enema program as part of usual care from their healthcare providers. The study collects information at three time points: before starting the enema program, 6 months after, and 1 year after. Additionally, interviews with children, adults, and caregivers explore experiences with managing bowel incontinence and maintaining enema programs. Participants will complete online surveys at these time points to assess bowel continence, bowel symptoms, satisfaction, quality of life, self-management, independence, and healthcare use related to bowel issues. The study tracks how well each enema program works and how it affects daily life. The total participation duration is one year, with data collected to help improve bowel care and quality of life for people with spina bifida.