N/A N=280 The TOBY Children Study
Cerebral Palsy · Hypoxia-Ischemia, Brain
Primary: Number of Survivors With an IQ > 84 — 75; 52 participants
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=500 High-dose Erythropoietin for Asphyxia and Encephalopathy
Neonatal Encephalopathy · Birth Asphyxia
Primary: Number of Participants With Death or Neurodevelopmental Impairment — 126; 110 Participants
Phase 1 N=9 Caffeine for Hypoxic-Ischemic Encephalopathy
Hypoxic-Ischemic Encephalopathy
Primary: Area Under Plasma Concentration-time at Time t (AUC0-t) for Caffeine — 1137.36; 1177.94; 2213.26; 2768.25 mg*hr/L
N/A N=325 TOBY (TOtal Body hYpothermia): a Study of Treatment for Perinatal Asphyxia
Asphyxia Neonatorum · Hypoxia · Encephalopathy
Primary: Combined Incidence of Mortality and Severe Neurodevelopmental Disability in Survivors — 74; 86 participants
Phase 2 N=22 Abnormal Ventilatory Response to Carbon Dioxide: a Potential Biomarker for Seizure Induced Respiratory Depression & Modification by SSRI
Epilepsy · SUDEP
Primary: Study Recruitment Rate — 3.8 participants/3 months
N/A N=92 Neuroprotective Effects of Hypothermia Combined With Inhaled Xenon Following Perinatal Asphyxia
Hypoxic Ischaemic Encephalopathy
Primary: Lactate (Lac) / N Acetyl Aspartate (NAA) Ratio on Magnetic Resonance Spectroscopy — 0.25; 0.28 ratio
Phase 2 N=30 Darbe Administration in Newborns Undergoing Cooling for Encephalopathy
Hypoxic Ischemic Encephalopathy
Primary: The Pharmacokinetic Profile of Darbe After the First Dose During Cooling — 180,866; 26,555 AUC (h*mU/L) — p=0.006