Perveen 2016.
| Study characteristics | |
| Methods | Randomised controlled trial |
| Participants | Inclusion criteria: (quote:) "babies of > 2 kg admitted in NICU within 48 hours of birth with neonatal seizures due to perinatal asphyxia with clinical features of HIE." "If seizures persisted even after correction of hypoglycaemia and hypocalcaemia, babies were randomised for intervention to either levetiracetam or phenobarbitone." Exclusion criteria: anticonvulsant prior to admission; serum creatinine greater than 2 mg/dL; major congenital malformations; refractory shock; need for assisted ventilation at admission. LEV group, 30 patients Gestational age (weeks), mean (SD): 38.29 (1.03) Weight (kg), mean (SD): 2.78 (0.33) Male: 19 (63.3) Intramural deliveries: 11 (36.7) > 0.05 HIE stage 2: 24 (80) HIE stage 3: 6 (20) Duration of hospital stay, mean (SD): (days) 7.7 (4.56) Need of boluses and inotropic support: 15 (50) Sepsis screen positive: 3/30 (10) ph < 7.0 at admission: 19/30 (63.3) Base deficit > 12: 20/30 (66.6) PB group, 30 patients Gestational age (weeks), mean (SD): 38.43 (1.10) Weight (kg), mean (SD): 2.90 (0.31) Male: 22 (73.3) Intramural deliveries: 13 (43.3) HIE stage 2: 25 (83.3) HIE stage 3: 5 (16.6) Duration of hospital stay (days), mean (SD): 8.9 (4.91) Need of boluses and inotropic support: 10 (30) Sepsis screen positive: 2/30 (6.6) ph < 7.0 at admission: 17/30 (56.6) Base deficit > 12: 18/30 (60) The study was performed at a single centre in Meerut, India, from July 2014 to December 2015. |
| Interventions | Intravenous LEV, loading dose of 60mg/kg diluted in 30 ml normal saline given slowly over 15 ‐ 20 minutes, under cardio respiratory system monitoring. If seizures were controlled, maintenance was continued (15mg/kg/day every 12 hr) for 5 days. If seizures persisted after the loading dose of LEV, babies crossed over to receive IV phenobarbitone, followed by maintenance (5 mg/kg/day every 12 hr) for 5 days. Intravenous PB, loading dose of 20mg/kg diluted in 1:10 of distilled water given slowly at the rate of 1mg/kg/min under strict cardiorespiratory monitoring. If seizures persisted, the babies were crossed over to treatment with IV levetiracetam. If seizures were controlled then they were kept on maintenance dose of both drugs. If seizures persisted despite crossover, the babies were treated as per unit policy. |
| Outcomes | Primary outcome: (quote:)"Clinical control of seizure activity ". (Quote:)"Seizures were considered to be controlled if the baby was seizures free 24 hrs after last seizures." Secondary outcomes: (quote:) "safety profile of levetiracetam, electrical seizures after control of clinical seizure, time taken to control seizures, and neurological examination till 6 months." |
| Notes | According to the others there was no external funding. The authors reported not having potential conflicts of interest to disclose. |