Khan 2020.
Study characteristics | |
Methods | Randomised controlled trial |
Participants | Inclusion criteria: (quote:) "premature newborns with a gestational age more than 34 weeks to less than 42 weeks and a birth weight of more than 2000 gm with neonatal seizures" Exclusion criteria: (quote:) "seizures caused by hypoglycaemia, hypocalcaemia or dyselectrolytaemia and sepsis." (Quote:) "Patients [who] had already received more than single loading doses of PB or medication with any other ASMs." LEV group, 50 patients Sex: male 30 (60.0); female 20 (40.0) Gestational age (weeks): Premature (< 37) 6 (12.0); full term (37‐42) 44 (88.0) Birth weight (gm): 2000‐< 2500 8 (16.0); 2500‐4000 42(84.0) Breathing status of neonates delivered outside hospital (n = 26): Within 1 minute 19 (79.2); breathing < 5 minutes 5 (20.8) PB group, 50 patients Sex: male 37 (74.0); female 13 (26.0) Gestational age (weeks): Premature (< 37) 5 (10.0); full term (37‐42) 45 (90.0) Birth weight (gm): 2000‐< 2500 9 (18.0); 2500‐4000 41(82.0) Breathing status of neonates delivered outside hospital (n = 14): Within 1 minute 31 (86.1); breathing < 5 minutes 5 (13.9) The study was performed at a single centre in Dhaka, Bangladesh. Patients were enrolled between July 2013 and June 2014. |
Interventions | Intravenous LEV, loading dose of 50 mg/kg with 10 mg/kg/dose 8‐hourly (maintenance) Intravenous PB, loading dose of 20 mg/kg with 5 mg/kg/day 12‐hourly (maintenance) If seizures recurred, a second or third loading of PB were given as a dose of 10 mg/kg. |
Outcomes | (Quote:) "Control of seizures and time required to control seizures" (Quote:)"Study end point was up to 48 hours but if seizure was not controlled within 48 hours it was labeled as treatment failure." |
Notes | (Quote:) "Seizures were diagnosed clinically. No continuous EEG monitoring was performed at
time of diagnosis and enrolment." Information on external funding and possible conflicts of interests of the authors was not included in the manuscript. |