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. 2023 Oct 24;2023(10):CD014967. doi: 10.1002/14651858.CD014967.pub2

Gowda 2019.

Study characteristics
Methods Randomised controlled trial
Participants Inclusion criteria: (Quote:) "Outborn neonates (age 0‐28 days) with clinical seizures". (Quote:) "Neonatal seizures were clinically defined as
abnormal, stereotyped and paroxysmal dysfunction in the CNS, occurring within the first 28 days after birth in full‐term infants or before 48 weeks of gestational age in preterm infants."
Exclusion criteria: (Quote:) "Neonates with hypoglycaemia, hypocalcaemia, hypomagnesaemia, those who received anticonvulsants prior to enrolment, and those with major congenital malformations e.g. congenital heart defects, neural tube malformations, diaphragmatic hernia, choanal atresia, oesophageal atresia, tracheo‐oesophageal fistula, omphalocele, gastroschisis, intestinal obstruction and imperforate anus".
LEV group, 50 patients
Age (days), mean (SD): 9.8 (8.50)
Male, n (%): 28 (56) 
Mode of delivery, n (%)
Vaginal: 35 (70) 
Caesarian: 15 (30) 
Gestation, n (%)
Term: 40 (80), 42 (84)
Preterm: 10 (20), 08 (16)
Birth weight (kg), mean (SD): 2.56 (0.64) 
Aetiology of seizures, n (%)
Hypoxic ischaemic encephalopathy: 20 (40) 
Neonatal sepsis/meningitis: 18 (36) 
Intracranial haemorrhage: 3 (6) 
Benign neonatal epilepsy syndrome: 2 (4) 
Malignant neonatal epilepsy syndrome: 1 (2) 
Cortical malformation: 1 (2) 
Inborn errors of metabolism: 1 (2) 
Unknown: 4 (8)
PB group, 50 patients
Age (days), mean (SD): 8 (8.33)
Male, n (%): 28 (56)
Mode of delivery, n (%)
Vaginal: 36 (72)
Caesarian: 14 (28)
Gestation, n (%)
Term: 42 (84)
Preterm: 08 (16)
Birth weight (kg), mean (SD): 2.73 (0.64)
Aetiology of seizures, n (%)
Hypoxic ischaemic encephalopathy: 24 (48)
Neonatal sepsis/meningitis: 15 (30)
Intracranial haemorrhage: 2 (4)
Benign neonatal epilepsy syndrome: 1 (2)
Malignant neonatal epilepsy syndrome: 1 (2)
Cortical malformation: 1 (2)
Inborn errors of metabolism: 2 (4)
Unknown: 4 (8)
The study was performed at a single neonatal intensive care unit in Bangalore, India, between November 2014 and April 2016.
Interventions Intravenous LEV (20 mg/kg) at a rate of 1 mg/kg/min under cardiorespiratory monitoring. If seizures terminated, LEV was continued as maintenance at 20 mg/kg/day in 2 divided doses. If seizures continued, another loading dose of LEV (20 mg/kg) was injected, and if seizures still persisted, patient was switched over to PB.
Intravenous PB (20 mg/kg) administered in the dose of 20 mg/kg diluted in 1:10 normal saline given intravenously slowly at the rate of 1 mg/kg/min under cardiorespiratory monitoring; if seizures were terminated, it was continued at 5 mg/kg/day in 2 divided doses as maintenance. Another loading dose of 10 mg/kg of PB was administered in neonates who failed to respond, and if seizures still persisted after 2 loading doses, patient was switched over to LEV.
Outcomes Primary outcomes: (quote:) "proportion of patients achieving cessation of seizures following the first or second dose of the drug (PB or LEV), and those remaining seizure‐free for next 24 hours". (Quote:)"Termination of seizures was defined clinically if there were no abnormal movement/eyeball deviation/nystagmus, no change in heart rate, no change in respiration/saturation and autonomic dysfunction".
Secondary outcomes: proportion of patients experiencing (quote:)"adverse events occurring within two hours of drug administration, including desaturation, reduced respiratory rate, increased ventilator support requirement,
arrhythmias, blood pressure, or heart rate fluctuations by more than 10% compared to the previous 2 hours, or if vasopressors were initiated or increased".
Notes The authors stated there was no external funding.
The authors reported not having potential conflicts of interest to disclose.