Phase 2 N=52 Clinical Trial on Treatment of Intraventricular Hemorrhage
Intraventricular Hemorrhage
Primary: 30-day Mortality — 1; 1; 6 Number of participants
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Phase 2 N=256 Effects of Delayed Cord Clamp and/or Indomethacin on Preterm Infant Brain Injury
Intraventricular Hemorrhage · Periventricular Leukomalacia · Brain Injury
Primary: Percent of Survivors With no Severe IVH (Grades 3 or 4) or PVL — 22.2; 14.9; 17.1; 10.9 percent of participants
Phase 3 N=500 Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III
Intraventricular Hemorrhage
Primary: Participants With Modified Rankin Scale (mRS) <=3 - Dichotomized Analysis — 47.6; 44.9 percentage of participants — p=0.554
Phase 3 N=431 Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial
Intraventricular Hemorrhage (IVH) · Bleeding in the Brain · Prematurity
Primary: IVH at 5 Postnatal Days — 25; 40 IVH
N/A N=2,839 The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial
Intracerebral Hemorrhage · Stroke · Hypertension
Primary: A Composite of Death or Dependency, With Dependency Being Defined by a Score of 3 to 5 on the Modified Rankin Scale (mRS) — 719; 785 participants
Phase 2 N=294 Intracerebral Hemorrhage Deferoxamine Trial - iDEF Ttrial
Intracerebral Hemorrhage
Primary: Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 90 Days — 48; 47 Participants
Phase 1 N=7 Conivaptan for the Reduction of Cerebral Edema in Intracerebral Hemorrhage- A Safety and Tolerability Study
Cerebral Hemorrhage · Cerebral Edema · Intracerebral Hemorrhage
Primary: Patient Tolerance of Conivaptan — 0; 0; 1; 0 Participants
N/A N=180 Detecting Traumatic Intracranial Hemorrhage With the InfraScanner 2500™ in Uganda
Head Trauma · Crushing Skull Injury · Head Injury
Primary: Infrascanner 2500™ Diagnostic Performance — 79; 65; 27; 9 Participants
Phase 3 N=1 CEUS Evaluation of Hypoxic Ischemic Injury
Hypoxic-Ischemic Encephalopathy · Brain Ischemia Hypoxia
Primary: Detection of Brain Perfusion Abnormalities Using Contrast-enhanced Ultrasound — 1; 0 Participants
Phase 3 N=499 Minimally Invasive Surgery Plus Rt-PA for ICH Evacuation Phase III
Intracerebral Hemorrhage
Primary: Dichotomized, Adjudicated Modified Rankin Scale Score 0-3 vs. 4-6 at 365 Days Post Ictus (Adjusted) — 110; 100; 139; 140 Participants — p=0.73
N/A N=400 Investigation of Clot in Ischemic Stroke and Hematoma Evacuation
Ischemic Stroke · Intracranial Hematoma
Primary: Clot Specimen Histology — 373; 12 Count of specimen
N/A N=37 Ventriculostomies in SAH: ICP Open or Not?
Subarachnoid Hemorrhage
Primary: Cerebral Artery Vasospasm — 16; 7 Participants
Phase 2 N=29 Efficacy, Safety and Tolerability of BAF312 Compared to Placebo in Patients With Intracerebral Hemorrhage (ICH).
Hemorrhagic Stroke · Intracerebral Hemorrhage (ICH)
Primary: Absolute Perihematoma Edema (aPHE) Volume Measured by Computed Tomography (CT) Scan After Intracerebral Hemorrhage (ICH) — 55.09; 52.50 mL — p=0.585
N/A N=117 External Ventricular Drainage Post-Market Clinical Follow-up Registry
Cerebrospinal; Disorder
Primary: Anticipated Drainage of Cerebrospinal Fluid (CSF) — 116 Participants
N/A N=25 Biologic Mechanisms of Early Exercise After Intracerebral Hemorrhage
Intracerebral Hemorrhage · Acute Ischemic Stroke
Primary: Change in Interleukin-1beta Level in Blood (Picogram/Milliliter)
Phase 2 N=96 Normobaric Hyperoxia for Intracerebral Hemorrhage
Normobaric Hyperoxia · Intracerebral Hemorrhage
Primary: Percentage of Patients With mRS 0-3 — 39; 27 Participants
Phase 2 N=110 Minimally Invasive Surgery and rtPA for Intracerebral Hemorrhage Evacuation
Intracerebral Hemorrhage
Primary: Safety Outcome Number 1: Rate of Mortality — 9.5; 14.8; 7.1 percentage of participants — p=0.324
N/A N=30 Intra-Abdominal Hypertension in Neonatal Intensive Care Patients
Intra-Abdominal Hypertension
Primary: Intra-abdominal Pressure(IAP) Measurements in NICU Patients. — 1219 IAP measurements
Phase 4 N=92 Efficacy of High-dose Intravenous Immunoglobulin Therapy for Hyperbilirubinemia Due Rh Hemolytic Disease
Hyperbilirubinemia · Erythroblastosis, Fetal
Primary: Need of Exchange Transfusion — 6; 7 participants — p=0.765
Phase 2 N=92 The Spot Sign for Predicting and Treating ICH Growth Study
Intracerebral Hemorrhage
Primary: Number of Study Subjects With Life-threatening Thromboembolic Complications — 1; 0; 0 Participants — p=1.00
Phase 1 N=60 Antihypertensive Treatment in Acute Cerebral Hemorrhage
Intracerebral Hemorrhage · Hypertension · Stroke
Primary: Particpants Who Achieve and Maintain the Systolic Blood Pressure Goals for Each Treatment Tier. — 18; 20; 22; 7 participants — p=< 0.01
N/A N=11 Therapeutic Intervention Supporting Development From NICU to 6 Months for Infants Post Hypoxic-Ischemic Encephalopathy
Cerebral Palsy · Hypoxic-Ischemic Encephalopathy
Primary: Feasibility of the Neonatal Intensive Care Unit Component of the Intervention. — 0; 1 Participants
N/A N=77 Brain Imaging and Developmental Follow up of Infants Treated With Erythropoietin
Prematurity
Primary: Full Scale IQ, Performance IQ, Verbal IQ, Executive Function — 79; 91; 103; 83 standardized score on a scale
Phase 3 N=35 Clevidipine in the Treatment of Patients With Acute Hypertension and Intracerebral Hemorrhage (ACCELERATE)
Hypertension · Hemorrhage
Primary: Median Time to Achieve Target SBP Range (≤160 mmHg to ≥140 mmHg) Within 30 Minutes of Initiation of Clevidipine — 5.5 minutes
N/A N=150 Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight Infants
Iron Deficiency Anemia
Primary: Hematocrit (Hct) at 36 Wks Post Menstrual Age (PMA) — 29.2; 28.2 % Hematocrit — p=0.59
N/A N=34 Cardiac and Cerebral Hemodynamics With Umbilical Cord Milking Compared With Early Cord Clamping
Birth Asphyxia With Neurologic Involvement
Primary: StO2 in the First 10 Minutes of Life — 70; 74.5 percent
Phase 2 N=6 Safety & Tolerability of Hypertonic Saline Administration Via Intraosseous Access
Stroke · Intracranial Hypotension · Cerebral Edema
Primary: Number of Subjects With Tissue Damage — 0 Participants
Phase 2 N=30 Safety Study of Intravenous Immunoglobulin (IVIG) Post-Portoenterostomy in Infants With Biliary Atresia
Biliary Atresia
Primary: Feasibility of IVIG Treatment — 23 Participants
N/A N=111 Cerebral Oxygenation and Autoregulation in Preterm Infants
Intraventricular Hemorrhage of Prematurity · Complications of Prematurity
Primary: Mortality Before Hospital Discharge — 11 Participants
N/A N=20 Perinatal Stroke: Understanding Brain Reorganization
Stroke · Hemiparesis
Primary: Cortical Excitability MEP Amplitude (µV) — 325 µV