View clinical trials related to Hypoxic-ischemic Encephalopathy.
Filter by:The objective of our study is to investigate the association of umbilical cord abnormalities with adverse pregnancy outcomes. The umbilical cord parameters that will be investigated as part of this study include the umbilical cord coiling index (UCI), umbilical cord (UC) diameter, umbilical vein (UV) diameter, UV flow velocity and the presence of nuchal cord. The UCI, UC, UV diameter & flow and presence of nuchal cord will be measured in routine unselected populations at 20-22 weeks and 35-37 weeks gestation during the study period. We will also measure the UC and UV diameter in a nested population of high-risk pregnancies attending our placental disorders clinic which have been deemed to be at risk of having adverse pregnancy outcomes. Primary objective: To investigate if prenatal assessment of UCI, UC, UV diameter & flow and presence of nuchal cord measured routinely in unselected screened populations at 20-22 weeks and 35-37 weeks' can provide an independent prediction of pregnancies that develop adverse pregnancy outcomes. Secondary objectives: To assess the correlation of UC and UV diameter measured by ultrasound scan and fetal magnetic resonance imaging in prediction of pregnancy outcome. To examine the association of these umbilical cord measurements and observations in a nested cohort of pregnancies in the high-risk placental disorders clinic.
This is a prospective, single center, pharmacokinetic study of intravenous hydrocortisone therapy for systemic low blood pressure during hypothermia treatment in asphyxiated newborns. Patients will be allocated to hydrocortisone supplementation while receiving conventional inotropic therapy as needed. The hypothesis is that a detailed study of hydrocortisone pharmacokinetics during therapeutic hypothermia would help to personalize steroid supplementation in asphyxiated neonates. As the overall metabolic rate decreases with lower body temperature, drug metabolism is likely to be reduced as well, and lower doses, or less frequent dosing will be sufficient to achieve the targeted steroid range and biological effects in asphyxiated neonates with relative adrenal insufficiency. Thus, the investigators are planning to measure initial, baseline serum cortisol levels and serial serum cortisol levels after hydrocortisone supplementation in cooled asphyxiated neonates.
The purpose of the research is to determine if the Hepatitis B vaccine after birth provides enough protection after cooling for Hypoxic Ischemic Encephalopathy (HIE). To do this, Hepatitis B titers (blood sample) would be taken before, during, and after administering of the Hepatitis B vaccine series to measure efficacy of the vaccine.
Hypoxic-ischemic encephalopathy (HIE) affects approximately 4,000 to 12,000 persons annually in the United States. Mortality from HIE has been reported up to 60%, with at least 25% of survivors left with significant neurocognitive disability. Despite this vital unmet medical need, no pharmacological adjunct or alternative therapy has proven beneficial in improving outcomes in neonatal HIE. RLS-0071 is a novel peptide being developed for the treatment of neonatal HIE. This study is designed to evaluate the safety and tolerability of RLS-0071 in the treatment of newborns with moderate or severe HIE.
The transition period to full oral feeding in infants with perinatal asphyxia is important in predicting long-term outcomes. The transition to independent oral feeding is accepted as a discharge criterion by the American Academy of Pediatrics, and the long transition from tube feeding to oral feeding prolongs the discharge process. Prolonged transition to oral feeding increases maternal stress as it delays gastrointestinal problems, mother-infant interaction and attachment, as well as increasing health expenditures. Due to long-term feeding tube use; Infection, leakage, delay in wound healing, trauma caused by repeated placement, as well as oral reluctance are observed. In asphyxia infants, in whom oral-motor dysfunction is common, the transition to oral feeding takes a long time and tube feeding support is required. The effect of hypothermia, which is a general therapeutic intervention that reduces the risk of mortality and morbidity in infants with asphyxia, on oral feeding has been previously studied and shown to have a positive effect. They also found that MR imaging in infants with asphyxia and the need for gastrostomy and tube feeding in those with brainstem involvement were associated. Various interventions that affect the transition to oral nutrition positively and shorten the discharge time are included in the literature. Stimulation of non-nutritive sucking (NNS) is the most frequently preferred method among these interventions. It has been shown in studies that there are no short-term negative effects of NNS stimulation with the help of a pacifier or gloved finger, and some clinical benefits such as better bottle feeding performance, acceleration of discharge and transition to oral feeding. The effect of the NNS stimulation method, which has been shown to be effective in preterm infants with large-scale randomized controlled studies, is not known exactly. The aim of this study is to examine the effect of NNS stimulation applied to oral feeding, feeding skills, weight gain and discharge in asphyxia infants receiving hypothermia treatment.
The main purpose of this study is to determine the maximum safe tolerated dose of LEV in the treatment of neonatal seizures. Our hypothesis is that optimal dosing of Levetiracetam (LEV) to treat neonatal seizures is significantly greater than 60mg/kg. This study will be an open label dose-escalation, preliminary safety and efficacy study. There will be a randomized control treatment component. Infants recognized as having neonatal seizures or as being at risk of developing seizures will be recruited and started on continuous video EEG monitoring (CEEG). Eligibility will be confirmed and consent will be obtained. In the first 2 phases of the study, neurologists will identify neonates with mild-moderate seizure burden (less than 8 minutes cumulative seizure activity per hour), appropriate for study with LEV, and exclude patients with higher seizure burden where treatment with PHB is more appropriate. Phase 3 of the dose escalation will only proceed if additional efficacy of LEV has been demonstrated in phases 1 and 2. In Phase 3 we will recruit neonates with seizures of greater severity up to 30 minute seizure burden/hour. This will make the final results of study more generalizable. If seizures are confirmed, enrolled subjects will receive 60mg/kg of LEV. Subjects whose seizures persist or recur 15 minutes after the first infusion is complete, subjects will then be randomized in the dose escalation study. Patients in the dose escalation study will be randomly assigned to receive either higher dose LEV or treatment with the control drug PHB in a 3:1 allocation ratio, stratified by site. Funding Source- FDA OOPD
Study Aims Pilot study: Due to the large recruitment goal and length of the project, the study team/PIs will evaluate the first cohort of 6-10 participants to refine study procedures and study-related materials. If no major modifications are made to the protocol as a result of this evaluation, data from these participants will be included for analysis. Aim 1: Evaluate the efficacy of an early, evidence-based, clinical experience-based therapeutic intervention (from the NICU to 12-months corrected age) on improving motor function and reducing severity of motor delays in infants at 12-months corrected age. The investigators hypothesize that the intervention group will demonstrate an average 8-point difference (0.5 standard deviation) compared to the standard of care group. [an 8-point difference is considered a clinically meaningful difference] Aim 2: Evaluate the early effects (i.e., before 12 months) of a therapeutic intervention, provided from NICU to 12-months corrected age, on motor function and severity of motor delay. The Investigators hypothesize that a statistically significant higher percentage of infants in the intervention group will demonstrate improved motor function and reduced severity of motor delays, compared to the standard of care group-assessed using sensors, the NSMDA and TIMP-as early as 3-months corrected age. Aim 3: Evaluate whether an early intervention that focuses on caregiver engagement improves caregiver well-being. The invetigators hypothesize that an intervention that focuses on supporting and addressing the individual needs of the caregiver will improve caregiver well-being. The investigators will evaluate these effects using the PedsQL (Family Impact Module).
This research study will combine non-invasive spinal stimulation with mobility devices to examine the acute impact of the individual and combined effects of these innovative techniques on mobility in children with cerebral palsy.
Infants are at risk of developing motor and cognitive neurodevelopmental disabilities as a sequelae to hypoxic-ischemic brain injury during the perinatal period. It is an ongoing challenge to predict the severity and extent of future developmental impairment during the neonatal period. This study will help test the feasibility of conducting a large-scale study that evaluates the role of diffuse optical tomography as a bedside neuroimaging tool in complementing the prognostic value of conventional and diffusion weighted MRI for predicting neurodevelopmental outcome in neonates with perinatal hypoxic-ischemic brain injury.
Sovateltide (PMZ-1620; IRL-1620) is targeted to be used as a "Treatment for hypoxic-ischemic encephalopathy in neonates," which is a life-threatening condition. Sovateltide augments neuronal progenitor cell differentiation and better mitochondrial morphology and biogenesis to activate a regenerative response in the central nervous system. The only treatment for HIE is therapeutic hypothermia with limited success, and studies indicate that sovateltide may be beneficial in these patients.