Recent Key Papers


Recent Key Trials and Studies in Neonatal Neurology/Neurocritical Care: 2018 – 2020

 

Recently Published

 

Randomized, Controlled, Double-Blind Trial of Bumetanide to Treat Neonatal Seizures, 2020

NCT: NCT00830531

Randomized, controlled trial of bumetanide as add-on therapy to phenobarbital compared with standard-therapy controls (phenobarbital alone) in neonates with seizures refractory to phenobarbital load. Results demonstrated additional reduction in seizure burden attributable to bumetanide over phenobarbital without increased serious adverse effects. PMID: 33201535

 

NEOLEV2 (Efficacy of Intravenous Levetiracetam in Neonatal Seizures), 2020

NCT: NCT01720667

Randomized trial of levetiracetam vs. phenobarbital for first-line treatment of seizure in neonates.  Phenobarbital demonstrated superior control of seizures compared to levetiracetam, although with a small increased incidence of adverse events. PMID: 32385134

 

PENUT (Preterm Erythropoietin Neuroprotection Trial), 2020

NCT: NCT01378273

Randomized, controlled trial of VLBW infants receiving placebo or erythropoietin for neuroprotection every 48 hours for six doses.  Primary outcome was reduction in death or severe neurodevelopmental outcomes at 2 year of age.  Results demonstrated no difference between erythropoietin and placebo groups. PMID: 31940698

 

Late Hypothermia for Hypoxic-Ischemic Encephalopathy, 2018

NCT: NCT00614744

Neonates diagnosed with moderate or severe encephalopathy but not cooled by 6h of life were randomized to TH or conventional treatment up to 24h of life.  Given small sample size, Bayseian analysis was conducted and estimated 75% probability of any reduction in death or disability. PMID: 29067428, Commentary on Bayesian analysis: 29067406

 

PRIME (Prospective Research in Infants With Mild Encephalopathy), 2018

NCT: NCT01747863

Infants with mild encephalopathy and without TH treatment were enrolled in multicenter prospective study including EEG, imaging and 2-year follow-up. Approximately 50% of infants had abnormalities by the time of hospital discharge and 16% had neurodevelopmental impairment at 2 years.

PMID: 30250303, 29095433

 

 

 

 



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