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Recent Key Trials and Studies in Neonatal Neurology/Neurocritical Care
2021
Hypothermia for moderate or severe neonatal encephalopathy in low-income and middle-income countries (HELIX): a randomised controlled trial in India, Sri Lanka, and Bangladesh.
Thayyil S, Pant S, Montaldo P, Shukla D, Oliveira V, Ivain P, Bassett P, Swamy R, Mendoza J, Moreno-Morales M, Lally PJ, Benakappa N, Bandiya P, Shivarudhrappa I, Somanna J, Kantharajanna UB, Rajvanshi A, Krishnappa S, Joby PK, Jayaraman K, Chandramohan R, Kamalarathnam CN, Sebastian M, Tamilselvam IA, Rajendran UD, Soundrarajan R, Kumar V, Sudarsanan H, Vadakepat P, Gopalan K, Sundaram M, Seeralar A, Vinayagam P, Sajjid M, Baburaj M, Murugan KD, Sathyanathan BP, Kumaran ES, Mondkar J, Manerkar S, Joshi AR, Dewang K, Bhisikar SM, Kalamdani P, Bichkar V, Patra S, Jiwnani K, Shahidullah M, Moni SC, Jahan I, Mannan MA, Dey SK, Nahar MN, Islam MN, Shabuj KH, Rodrigo R, Sumanasena S, Abayabandara-Herath T, Chathurangika GK, Wanigasinghe J, Sujatha R, Saraswathy S, Rahul A, Radha SJ, Sarojam MK, Krishnan V, Nair MK, Devadas S, Chandriah S, Venkateswaran H, Burgod C, Chandrasekaran M, Atreja G, Muraleedharan P, Herberg JA, Kling Chong WK, Sebire NJ, Pressler R, Ramji S, Shankaran S; HELIX consortium.
Lancet Glob Health. 2021 Sep;9(9):e1273-e1285. doi: 10.1016/S2214-109X(21)00264-3. Epub 2021 Aug 3.
PMID: 34358491 Free PMC article. Clinical Trial.
Safety of Early Discontinuation of Antiseizure Medication After Acute Symptomatic Neonatal Seizures.
Glass HC, Soul JS, Chang T, Wusthoff CJ, Chu CJ, Massey SL, Abend NS, Lemmon M, Thomas C, Numis AL, Guillet R, Sturza J, McNamara NA, Rogers EE, Franck LS, McCulloch CE, Shellhaas RA.
JAMA Neurol. 2021 Jul 1;78(7):817-825. doi: 10.1001/jamaneurol.2021.1437.
PMID: 34028496 Free PMC article
The ILAE classification of seizures and the epilepsies: Modification for seizures in the neonate. Position paper by the ILAE Task Force on Neonatal Seizures. Pressler RM, Cilio MR, Mizrahi EM, Moshé SL, Nunes ML, Plouin P, Vanhatalo S, Yozawitz E, de Vries LS, Puthenveettil Vinayan K, Triki CC, Wilmshurst JM, Yamamoto H, Zuberi SM. Epilepsia. 2021 Mar;62(3):615-628. doi: 10.1111/epi.16815. Epub 2021 Feb 1. PMID: 33522601
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2018-2020
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.