Neurodevelopmental Outcome in Newborn With Hypoxic-ischemic Encephalopathy Treated With Therapeutic...
EncephalopathyHypoxic IschemicThe goal of this observational study is to identify early signs of poor neurodevelopmental outcome by performing specific neurological, neurophysiological and neuroimaging assessments in newborns with hypoxic-ischemic encephalopathy treated with therapeutic hypothermia. The main questions it aims to answer are: Identify patients at risk of neuromotor, cognitive and epileptic sequelae Plan early rehabilitation programs and future trials on early neuroprotection in infant at risk of neurodevelopmental disability Participants will be involved in serial assessment: Before and after therapeutic hypothermia and before discharge: neurological assessment, according to the modified Sarna (t) score, Thompson's score and Hammersmith Neonatal Neurological Examination (HNNE); General Movement Assessment Amplitude integrated electroencephalogram (aEEG) within 6 hours of life, for 6 hours. Neonatal Cranial Ultrasonography within 6 hours of life, in the third and seventh day of life. Brain magnetic resonance imaging between 7 and 14 days. Electroencephalogram (EEG) within 7 days. After discharge study population will perform: EEG between 3 and 6 months. Neurological assessment using Hammersmith Infant Neurological Examination (HINE) at 3-6-9-12 months. General Movement Assessment at 3 months. Neurodevelopmental assessment using the Griffiths Mental Development Scales at 24 months. Cognitive assessment using the Wechsler Preschool and Primary Scale of Intelligence between 36 and 41 months. Motor performance assessment using Movement ABC between 42 and 48 months.
Neonatal Seizure Registry, GEnetics of Post-Neonatal Epilepsy
Neonatal SeizureHypoxic-Ischemic Encephalopathy4 moreThe NSR-GENE study is a longitudinal cohort study of approximately 300 parent-child trios from the Neonatal Seizure Registry and participating site outpatient clinics that aims to evaluate whether and how genes alter the risk of post-neonatal epilepsy among children with acute provoked neonatal seizures. The researchers aim to develop prediction rules to stratify neonates into low, medium, and high risk for post-neonatal epilepsy based on clinical, electroencephalogram (EEG), magnetic resonance imaging (MRI), and genetic risk factors.
Early Virtual Intervention for Infants With CP Following HIE Diagnosis
Cerebral PalsyHypoxic-Ischemic Encephalopathy2 moreThis will be a five year study that will be a prospective, randomized, controlled trial (RCT) to assess the effect of a virtual early intervention care delivery model in the provision of therapy to enhance the neurodevelopmental trajectory of infants with brain injury. In addition, the investigators will enhance understanding of the social and parental contributors to outcomes and the early health economic impact of a virtual clinic. The results of this study will help inform the design of a larger, multi-center randomized controlled trial.
Optimizing (Longer, Deeper) Cooling for Neonatal Hypoxic-Ischemic Encephalopathy(HIE)
InfantNewborn8 moreThe Optimizing Cooling trial will compare four whole-body cooling treatments for infants born at 36 weeks gestational age or later with hypoxic-ischemic encephalopathy: (1) cooling for 72 hours to 33.5°C; (2) cooling for 120 hours to 33.5°C; (3) cooling for 72 hours to 32.0°C; and (4) cooling for 120 hours to 32.0°C. The objective of this study is to evaluate whether whole-body cooling initiated at less than 6 hours of age and continued for 120 hours and/or a depth at 32.0°C in will reduce death and disability at 18-22 months corrected age.
Heart Beat Variability in Neonatal Encephalopathy
Neonatal EncephalopathyAsphyxia Neonatorum1 moreThis study will find out if analysing heartbeat in babies with brain injury, based on standard clinical monitors, can inform treatment decisions and monitor stress levels in real time
Florida Neonatal Neurologic Network
Hypoxic-Ischemic EncephalopathyCreate a database with selected medical information on infants born with hypoxic-ischemic encephalopathy (HIE). In addition, the following samples will be collected in a bio-repository for future studies: blood, urine, and buccal samples.
Hypoxic-Ischemic Encephalopathy Therapy Optimization in Neonates for Better Neuroprotection With...
Hypoxic-Ischaemic EncephalopathyPerinatal Asphyxia1 moreThis is a Phase I, open-label, single center trial to evaluate the feasibility and safety of low concentration CO2 gas mixture (5% CO2 + 95% air) inhalation in asphyxiated, cooled, mechanically ventilated newborns at risk of hypocapnia with The hypothesis is that hypocapnia, which is driven by hyperventilation in the presence of metabolic acidosis, is deleterious to the injured brain and can be safely avoided with low concentration CO2 inhalation.
Autologous Cord Blood Cell Therapy for Neonatal Encephalopathy
Neonatal EncephalopathyHypoxic-ischemic EncephalopathyThis is a pilot study to test feasibility and safety of intravenous infusion of autologous umbilical cord blood cells in the first 72 hours after birth if a neonate is born with signs of encephalopathy.
Preemie Hypothermia for Neonatal Encephalopathy
InfantNewborn8 moreThis study is a randomized, controlled trial to assess safety and effectiveness of whole body hypothermia for 72 hours in preterm infants 33-35 weeks gestational age (GA) who present at <6 hours postnatal age with moderate to severe neonatal encephalopathy (NE). The study will enroll infants with signs of NE at 18 NICHD Neonatal Research Network sites, and randomly assign them to either receive hypothermia or participate in a non-cooled control group.
Cord Blood for Neonatal Hypoxic-ischemic Encephalopathy
Neonatal Hypoxic Ischemic EncephalopathyThis is a pilot study to test feasibility of collection, preparation and infusion of a baby's own (autologous)umbilical cord blood in the first 14 days after birth if the baby is born with signs of brain injury.