The goal of this study is to compare the patient?s response using noninvasive ventilator modes of respiratory support only to standard treatment regimen. The standard treatment regimen includes all modes of respiratory support; High Flow Nasal Cannula (HFNC), Blow by O2 support, and O2 by nasal cannula or prong and standard medications for treatment of respiratory distress which include bronchodilators; albuterol, racemic epinephrine, hypertonic normal saline with and without ipratropium bromide, chest physical therapy and steroids. The fraction of oxygen (FiO2) will be adjusted to keep oxyhemoglobin saturation exceeds 92%. The study will evaluate the length of stay in the PICU and time to resolution of respiratory distress using a standardized scoring tool (Modified Pulmonary Index Score).
The purpose of this study is to understand factors contributing to managing emotions, behavior problems, and substance use among girls. Middle school adolescent girls will be asked about their thoughts and feelings about themselves and their ethnic group, perceptions, and discrimination. They will also report on their behavior and substance use. Their reactions to recent incidents of unfair treatment or disciplinary action will also be assessed.
The purpose of this project is to study validity of a newly developed pediatric tool, the Pediatric Awareness and Sensory Motor Assessment (PASMA), which will measure cognitive awareness for children with severe brain damage. Thirty children, between the ages of 3-21 years, with physician-documented severe brain damage and considered medically stable are needed for this study. Recruitment flyers will be disseminated at HMS School in Philadelphia, PA, iHope (school serving children with severe disabilities) in NY, NY, MUSC and the greater Charleston area community to recruit parents/legal guardians of children with severe brain damage. Once parental/legal guardian and physician consents are in place, participants will be evaluated using the PASMA 5 times within 10 days. The PASMA is made up of 5 domains that are olfactory, visual, auditory and vestibular, gustatory, and tactile. Test administration requires approximately 1 hour and can be completed in settings convenient for parents/legal guardians. The potential benefit to study participants is that the findings from the PASMA may identify sensory and motor strengths of participants. Knowledge of these strengths may enhance current rehabilitation and treatment plans, which may lead to functional improvements; although, this cannot be guaranteed. It is a goal of this study to evaluate PASMA validity. Once validity has been substantiated for the PASMA by means of further study, future children with severe brain injury, being evaluated with the PASMA, may have rehabilitation and treatments opportunities that are better informed, leading to greater improvement in functional and participatory outcomes.
The purpose of the study is to assess and qualify the clinical phenotype as well as adequately classify the motor component of the X-linked MCT8 transporter deficiency syndrome by performing neurological exams and MRI imaging of subjects with the MCT8 transporter deficiency and MRI imaging of age matching control patients. A total of 12 well-documented MCT8 deficiency patients and 20 age matching control subjects are expected to be recruited over a two year period fo this proposed study.
We propose a prospective observational analysis of near visual acuity and stereopsis in pseudophakic children. Visual acuity analysis will be standardized based on age per PEDIG protocols. Results will be stratified by age and by monocular versus binocular surgery. Children will be assessed in their appropriate corrective lenses to control for myopia as a confounding factor. Refractive error will be measured to optimize visual acuity measurement and assess for the potential role of astigmatism in preservation of near visual function.
Infants born early who are in the neonatal intensive care unit will be included if they meet national guidelines for retinopathy of prematurity (ROP) screening exams. Informed consent will be given to the parent(s) or legal guardians. 1.5-2 ml of blood will be drawn from a vein when the child is enrolled in the study and may be drawn again if the child requires treatment of eye disease. A cheek swab will also be obtained. These biologic samples will be shipped overnight to the University of Utah for genetic analysis. Analysis will determine if a change in gene expression causes retinopathy of prematurity. Infants enrolled in the study will be followed clinically per established ROP screening guidelines. They will not require additional study exams.
Parents who have infants in the MUSC NCU will be asked to give their opinions about the discharge process as their infants transition from receiving hospital care to being cared for at home. The parents will complete surveys and interviews to offer their feedback. The parents' opinions will be compared with the infant's unexpected readmission to the hospital after discharge, if it occurred. Parents will also decide what is most important for a successful discharge of the infant. The factors that parents consider to be most important will also be compared to which factors nurses find to be important.
This multi-center prospective study will validate the RLS as a tool to predict early and mid-term outcomes for five common congenital cardiac operations. The RLS study will develop the first validated tool for measurement of residual lesions following congenital heart surgery. The proposed project will also lay the groundwork for future projects, facilitating continuous quality improvement in congenital heart surgery.
The Hernia in Premies (HIP) Trial is a multi-site randomized clinical trial that is comparing two accepted treatment choices, surgery before or after neonatal intensive care unit (NICU) discharge, for inguinal hernia (IH) repair in premature infants. The reason we are doing this study is that surgeons and neonatologists currently do not know the best time to perform the hernia repair. Some providers recommend having the hernia fixed before discharge from the neonatal intensive care unit (NICU) and some believe waiting until after NICU discharge is better. Both treatments are standard options for IH repair in premature infants. Also, all babies that have IH repair receive anesthesia. We also do not know if the age of the child receiving anesthesia affects neurodevelopment. We are comparing the timing of anesthesia exposure between the two treatments (IH repair before or after NICU discharge) to help answer these questions.
By volunteering to take part in the HIP Trial, your child will be randomly assigned to have the operation before or after NICU discharge. This means that the timing of the repair operation will be determined by chance, like flipping a coin, and he/she has an equal chance of being treated before or after NICU discharge. We will be collecting information about your baby and the treatment that he or she receives, and how your baby recovers before and after the surgery. We will also collect information about your baby from clinic notes and results from your baby?s routine 2 year follow-up neurodevelopmental testing, where your child will be asked questions that measure cognitive, language, social and motor development. We will stop collecting information about your baby and your participation will end when your child is 2 years old. There are no extra medical tests or blood work being done for research purposes in the HIP trial.
This research study is for children between 6 years and 18 years of age who have been diagnosed with hypertension, or high blood pressure. Hypertension or high blood pressure is when someone?s blood vessels, called arteries, tighten too much. The study lasts 12 months and could involve up to 17 study visits. Compensation is available.
The main purpose of this study is to find out if the study drug, Azilsartan medoxomil (also called AZM, TAK-491, or AR14) is effective in controlling blood pressure in children 6 to less than 18 years of age and to find out if it is safe and well tolerated in this age group compared to placebo. The safety and effectiveness of AZM in children less than 18 years of age have not yet been established and currently are under investigation in the age group 1 to 17 years. This means it does not currently have FDA approval for use in children and adolescents.
Another purpose of the study is to compare a drug called losartan potassium (Cozaar) to AZM. Cozaar is an FDA approved drug that is used to treat high blood pressure in adults and children