N/A N=386 Clinical Use of a Neonatal MRI System
NICU MRI
Primary: Number of Participants With Adverse Events as Observed During and After Scanning. — 0 Participants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=657 Clinical Use of a New Neonatal MRI System
Magnetic Resonance Imaging
Primary: Number of Participants With Adverse Events as Observed During and After Scanning. — 4 Participants
N/A N=49 Development of a MR Scanner Capable of Being Sited in a Neonatal Intensive Care Unit (Firefly Sheffield)
Neonatal Neuroimaging
Primary: Image Diagnostic Quality for Phase 1 — 24 Participants
N/A N=63 Prospective Research in Infants With Mild Encephalopathy
Hypoxic-Ischemic Encephalopathy · Brain Injury · Neonatal Seizure
Primary: Percentage of Infants With Evidence of Neurological Dysfunction, Brain Injury and/or Abnormality. — 28 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=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
N/A N=45 MRI for Non-Invasive Imaging in Neonates and Children
Healthy · Cystic Fibrosis (CF) · Asthma
Primary: Ventilation Defects as Seen on Hyperpolarized Helium-3 MRI — 9; 13; 16 Participants
N/A N=15 Pilot Study: Safety of a Customized MRI System for Neonatal Imaging
Safety of a Customized NICU MRI System
Primary: Number of Participants With Adverse Events as Measured by Vital Signs, Change in Temperature, and Physical Exam — 0 Adverse Events
Phase 4 N=74 MRI and Neurodevelopment in Preterm Infants Following Administration of High-Dose Caffeine
Apnea of Prematurity · Intraventricular Hemorrhage · Brain Injury
Primary: White Matter Microstructural Maturation — 1.43; 1.42 apparent diffusion coefficient
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
Phase 2 N=62 Erythropoetin Neuroprotection for Neonatal Cardiac Surgery
Congenital Heart Disease · Hypoplastic Left Heart Syndrome · Transposition of the Great Arteries
Primary: Relative Difference in Total Maturity Score (TMS) From Preoperative Brain MRI to 7 Day Postoperative MRI — 12.1; 9.44 Percentage
N/A N=70 NEO Rehab Program for Premature Infants at Risk for Cerebral Palsy
Cerebral Palsy · Prematurity · Early Intervention
Primary: Acceptability — 70 Participants
N/A N=248 Trial to Improve Multisensory Neural Processing, Language & Motor Outcomes in Preterm Infants
Preterm Infant
Primary: Index of Multisensory Processing (IMP) — 31.4; 49.0; 35.6; 18.8 percentage of time
N/A N=11 Magnetic Resonance Imaging Using Innovative Pulse Sequences
Clinical Indication for a Head MRI
Primary: Number of Head Images Successfully Collected — 10 Images
N/A N=73 Rapid MRI for Acute Pediatric Head Trauma
Head Trauma · Image, Body
Primary: Sensitivity: Percentage of MRIs Correctly Identifying Clinically Important Intracranial Injury (True Positives) — 70 Percentage of MRIs correctly identifying
N/A N=12 MRI for Non-invasive Evaluation of Brain Stress
Craniosynostosis
Primary: Blood Flow and Perfusion — 26.8 ml/min/100g — p=0.004
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
N/A N=168 Preemie Hypothermia for Neonatal Encephalopathy
Infant, Newborn · Hypoxia, Brain · Hypoxia-Ischemia, Brain
Primary: Death or Moderate or Severe Disability — 29; 20 Participants
N/A N=189 Comparative Study of Conventional MR Images With Synthetically Reconstructed MR Images of the Brain
Clinical Indication for Brain MRI · Healthy Volunteers
Primary: Sensitivity of Pathological Findings (Full Analysis Set) — 0.66; 0.68 Proportion of participants
Phase 2 N=50 Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO)
Hypoxic-ischemic Encephalopathy · Neonatal Encephalopathy · Birth Asphyxia
Primary: Markers of Organ Function — 10; 6; 9; 12 participants
N/A N=44 Characterization of Pre-Term Neonatal Skin
Skin Disorder
Primary: Bilirubin Concentration From Non-invasive Diffuse Reflectance Spectroscopy (DRS) vs BiliChek — 0.814386451; 0.85422779; 0.67588721; 0.79293382 Correlation Coefficient…
Phase 1 N=22 PED NEONAT 20-000599 Fetal Body Composition
IUGR · Gestational Diabetes · Pregnancy Related
Primary: Maternal Visceral Adipose Tissue Volume — 97593; 169626; 96787 mm3
Phase 2 N=28 Mild Encephalopathy in the Newborn Treated With Darbepoetin
Neonatal Encephalopathy · Hypoxic-Ischemic Encephalopathy Mild
Primary: Normal Neurodevelopment — 13; 14 Participants
N/A N=39 Fetal and Neonatal Magnetophysiology
Fetal Arrhythmia · Abnormality in Fetal Heart Rate or Rhythm · Long QT Syndrome
Primary: Percentage of Subjects Experiencing Symptoms — 0; 0 Participants
N/A N=120 Neurocognitive Evaluation of Mild Traumatic Brain Injury in the Hospitalized Pediatric Population
Mild Traumatic Brain Injury · Concussion
Primary: The Feasibility of Inpatient Bedside Neurocognitive Testing of Pediatric Patients With Minor Traumatic Brain Injury. — 120 participants
Phase 2 N=106 Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism
Congenital Hyperinsulinism · Hyperinsulinism · Persistent Hyperinsulinemic Hypoglycemia of Infancy
Primary: The Accuracy of FDOPA PET to Identify Focal Forms of Hyperinsulinism — 40; 6; 3; 46 Participants
Phase 3 N=941 Preterm Erythropoietin Neuroprotection Trial (PENUT Trial)
Extreme Prematurity
Primary: Number of Participants With Death or Severe Neurodevelopmental Impairment (NDI) at 22-26 Months Corrected Age — 94; 97 Participants — p=0.05
Phase 2 N=106 Efficacy of Intravenous Levetiracetam in Neonatal Seizures
Neonatal Seizures
Primary: Neonates With Seizure Cessation When Given Levetiracetam (40-60 mg/kg) as First Line Therapy Compared to Phenobarbital (20-40mg/kg) — 15; 24 Participants — p=<0.001
N/A N=100 The Developmental Effects of NICU Positioning
Premature Birth of Newborn
Primary: NICU Network Neurobehavioral Scale (NNNS) — 3.1; 2.56 Asymmetry Score (units on a scale)