View clinical trials related to Spinal Dysraphism.
Filter by:Researchers are using Myocardial performance index (MPI) to assess fetal cardiac function before, during, and after fetal surgery in order to gain more knowledge about fetal cardiac function in high risk pregnancies and the relationship to outcomes of fetal surgical interventions.
The purpose of this study is to find out if there is a benefit to using the MyREADY Transition[TM] BBD App for brain-based disabilities, compared to not using it. To do this, some of the participants in this study will use the MyREADY Transition[TM] BBD App and others will not use the App. Everyone will continue to get the same care they have been getting (their usual care). The study team wants to see how youth will use the MyREADY Transition[TM] BBD App as they are getting ready to leave the children's hospital or children's treatment centre. And, they want to see if it will help youth to be knowledgeable about their own health. The study team hopes to see youth taking steps to develop the skills so they become better managers of their health. For example, this would include knowing about their medication or knowing when to ask for help from parents/caregivers and health care providers.
Spina bifida is a neurological abnormality characterized by an opening in the skin and exposure of the spinal cord on the back of the baby at the time of birth. The complete closure and separation of the spinal cord from the skin occurs in the first month of pregnancy. This form of spina bifida is associated with leg weakness, sensation loss, and bowel and bladder incontinence. The majority of patients (>80%) also develop increased fluid in the brain, called hydrocephalus, and require additional surgery to treat this problem. Standard treatment of myelomeningocele (MMC) involves closing the opening in the back within the first 3 days of life. The surgery releases the spinal cord from the skin and brings the skin edges together to prevent infection and injury to the exposed nerves. Of note, this type of surgery does not improve function. The investigators want to study the open in-utero fetal surgery technique in patients who are candidates for the standard open fetal repair technique but have a pre-pregnancy BMI of 35.0-40.0. The latter is a reason for exclusion for open fetal repair in most centers in the United States.
A collection of biological samples (cerebrospinal fluid [CSF] and blood) from patients under 6 years of age who are diagnosed with intraventricular hemorrhage or spina bifida.
With improved life expectancy over the last fifty years, spina bifida has become a disease of the adult. One of the major stakes for these patients is the preservation of a regular follow-up of uro-nephrologicals risk factors and of a respect for the rules of self management of their neurological bladder. The main objective of this study is to highlight a difference in the level of global self-esteem among a population of adult patients with spina bifida and a population of adult patients with traumatic spinal cord injury gained the same level of neurological.
This study is to evaluate the safety of Yulex gloves when used by individuals who have documented allergy to natural rubber latex from Hevea brasiliensis. Yulex is a latex from a different plant (Guayule) and in previous studies shows no cross-reactivity to Hevea latex and has not been allergenic in workers exposed to Yulex. The FDA has approved Yulex gloves for use in the general population and has recognized and labeled these gloves as Hevea Latex-free. The labeling still includes a precaution that Yulex gloves may pose a risk for development of allergy because Yulex does contain a small amount of Guayule protein. Yulex Corporation has proposed doing further studies to demonstrate safety and lack of allergenicity in a population that is prone to latex allergy. In the proposed pilot study, the investigators goal is to complete the protocol on 10 adults with spina bifida who are allergic to natural rubber latex who will wear Yulex gloves as part of their regular bladder and bowel care for approximately 30 minutes daily over a 3 month period. The investigators anticipate that the investigators will need to recruit and enroll up to 50 study participants to achieve a final sample of 10 adults with complete study data. Individuals with a history of anaphylaxis will be excluded from the study. The study participants will be tested for Yulex allergy by Glove Puncture Test as well as serology at the beginning and end of the study. The FDA Devices group has reviewed the study design and agreed that this is a suitable first pilot study.
In a collaborative effort with the Health Research Board, the national organization for medical research in the Republic of Ireland, individuals with neural tube defects (NTDs) or facial cleft defects and their parents will be studied. With the exception of a few well-described syndromes most cases of NTDs and facial clefts are not inherited in a Mendelian fashion. Nearly all incident cases occur in families with no prior history of the defects. The observed recurrence risk in families with an NTD child is 10-12 fold higher than the general population suggesting that inherited factors modify this risk. Historically, the incidence of NTDs in Ireland was 5-8 fold higher than the USA. The aim of this study is to identify the gene(s) involved in these defects using standard genetic epidemiology approaches, transmission disequilibrium testing and gene mapping strategies. We will initially evaluate genes known to be involved in folate metabolism and pattern formation (development of the body). The major outcomes measured will be aggregate allele frequencies in case groups compared to controls. Biochemical parameters in red cells and plasma will also be measured. Comparisons will be made between the presence of genetics variants, biochemical parameters and clinical phenotype. Characterizing the genes associated with these defects should provide insight into the etiology and metabolic processes that may be involved, furthering prevention and intervention efforts.