12 Clinical Trials for Various Conditions
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.
Currently, when premature infants develop severe intraventricular hemorrhage (IVH), a type of intracerebral bleed, there are no proven therapeutic interventions to prevent the devastating consequences of this event. These children will be likely to develop cerebral palsy or severe cognitive delays. The purpose of our study is to characterize differences in brain physiology, imaging, and function between premature infants with severe IVH and controls. The goals for gathering this information are to generate baseline data, which could facilitate early screening for complications of IVH in premature infants. These baseline data would also allow the design and implementation of early therapeutic interventions to help rehabilitate premature infants with severe IVH.
The purpose of this research study is to evaluate the safety and outcomes associated with the use of IRRAflow® System catheters in externally draining intracranial fluid to reduce intracranial pressure. This study will be comparing the IRRAflow® system to standard of care catheters used in the same procedure. The IRRAflow® system is FDA approved for this procedure.
The purpose of this multicenter trial is to determine if indomethacin prevents bleeding in the brain of very low birth weight preterm infants.
The purpose of this pilot trial is to test the safety and efficacy of administering one dose of vitamin E, via a tube into the stomach, to extremely preterm infants (less than 27 weeks gestation and less than 1000 grams birth weight). This pilot will examine whether a single dose of vitamin E will be absorbed into the infants' bloodstreams with resulting serum α-tocopherol level in the target range of 1-3 mg/dl.
The specific objective of this trial is to determine the lowest dose and dose frequency possible with the best pharmacokinetic and safety profile and it's ability to remove a blood clot from the ventricular system.
This study is being conducted to compare the incidence of preterm infants (up to 28+6 weeks GA) who achieve a peripheral oxygen saturation of 80 percent by 5 minutes of life (MOL) given mask CPAP/PPV with an FiO2 of 1.0 during DCC for 90 seconds (HI Group) to infants given mask CPAP/PPV with an FiO2 of .30 during DCC for 90 seconds (LO Group).
The primary goal of this study is to assess the occurrence of flushing interventions to address occlusions during the treatment of interventricular hemorrhage (spontaneous primary IVH or secondary IVH due to ruptured aneurysm).
The purpose of this prospective, single center, single arm registry is to assess technical feasibility, peri-procedural complications, post-procedure imaging outcomes, and 30-day safety outcomes in subjects with intraventricular hemorrhages utilizing the Artemis Neuro Evacuation Device in the hyper-acute phase.
Intraventricular hemorrhage and its resultant post-hemorrhagic hydrocephalus are significant risk factors for the development of neurodevelopmental delays in preterm infants. The purpose of this study is to determine 1) the incidence of progressive post-hemorrhagic ventricular dilatation (PHVD) in infants with severe intraventricular hemorrhage (IVH), 2) the effect of ventricular dilatation on brain status (cerebral oxygenation, electrical activity, and biomarkers of cerebral damage and repair), and 3) if using ventricular measurements, derived from cranial ultrasound to guide removal of cerebral-spinal fluid through an Omaya reservoir, will help resolve ventricular dilatation and decrease the need for ventriculo-peritoneal (VP) shunt insertion. The hypothesis of this research project is that, by using ventricular measurements to guide the frequency of CSF removal, the rate of VP shunt insertion will be decreased in preterm infants with severe IVH and PHVD. The investigators further hypothesize that cerebral injury, as measured by cerebrospinal fluid (CSF) concentration of biomarkers of neuronal and glial damage and inflammation, will decrease over time with resolution of PHVD.
The goal of this pilot study is to develop a novel caregiver education and coaching intervention for infants with intraventricular hemorrhage (IVH) and their caregivers during the NICU to home transition. The main questions it aims to answer are: 1. Development of a novel caregiver education and coaching intervention focused on infant development and caregiver needs to "bridge the gap" during the NICU to home transition 2. Pilot test the feasibility, acceptability, and efficacy of this program for infants with intraventricular hemorrhage (IVH) and their caregivers.
Intraventricular hemorrhage remains the most frequent, severe neurological complication of prematurity, occurring in 25-30% of preterm infants. Post-hemorrhagic ventricular dilation (PHVD) occurs in 25-50% of those infants, with over half requiring ventriculoperitoneal shunts. When suboptimally untreated, PVHD results in a 3-4 fold increase in neurodevelopmental delay. Despite the lifelong impact of PHVD on quality of life, little research has been done over the past 20 years to improve patient outcomes. The CENTRAL HYPOTHESIS of this project is that early treatment of PHVD will reduce shunt-dependence and improve neurodevelopmental outcome in preterm infants.