A pilot randomized, controlled, double-blind trial of bumetanide to treat neonatal seizures Controlled bumetanide trial for neonatal seizures.

ola Kala shared this article with you from Inoreader A pilot randomized, controlled, double-blind trial of bumetanide to treat neonatal seizures Controlled bumetanide trial for neonatal seizures. Μέσω pubmed: hearing and balance Related Articles A pilot randomized, controlled, double-blind trial of bumetanide to treat neonatal seizures Controlled bumetanide trial for neonatal seizures. Ann Neurol. 2020 Nov 17;: Authors: Soul JS, Bergin AM, Stopp C, Hayes B, Singh A, Fortuno CR, O'Reilly D, Krishnamoorthy K, Jensen FE, Rofeberg V, Dong M, Vinks AA, Wypij D, Staley KJ, Boston Bumetanide Trial Group Abstract OBJECTIVE: In the absence of controlled trials, treatment of neonatal seizures has changed minimally despite poor drug efficacy. We tested bumetanide added to phenobarbital to treat neonatal seizures in the first trial to include a standard-therapy control group. METHODS: A randomized, double-blind, dose-escalation design was employed. Neonates with postmenstrual age 33-44weeks at risk of or with seizures were eligible. Subjects with EEG-confirmed seizures after ≥20 and <40mg/kg phenobarbital were randomized to receive additional phenobarbital with either placebo (control) or 0.1, 0.2, or 0.3mg/kg bumetanide (treatment). Continuous EEG monitoring data from ≥2 hours before to ≥48 hours after study drug administration (SDA) were analyzed for seizures. RESULTS: Subjects were randomized to treatment (n=27) and control (n=16) groups. Pharmacokinetics were highly variable among subjects and altered by hypothermia. The only statistically significant adverse event was diuresis in treated subjects (48% vs. 13%, P=0.02). One treated (4%) and three control subjects died (19%, P=0.14). Among survivors, 2/26 treated subjects (8%) and 0/13 control subjects had hearing impairment, as did one non-randomized subject. Total seizure burden varied widely, with much higher seizure burden in treatment vs. control groups (median 3.1 vs. 1.2 minutes/hour, P=0.006). There was significantly greater reduction in seizure burden 0-4 hours and 2-4 hours post-SDA (both P<0.01) compared with 2-hour baseline in treatment vs. control groups with adjustment for seizure burden. INTERPRETATION: While definitive proof of efficacy awaits an appropriately powered phase III trial, this randomized, controlled, multicenter trial demonstrated an additional reduction in seizure burden attributable to bumetanide over phenobarbital without increased serious adverse effects. Future trials of bumetanide and other drugs should include a control group and balance seizure severity. This article is protected by copyright. All rights reserved. PMID: 33201535 [PubMed - as supplied by publisher] View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.