Akeel 2022.
Study characteristics | |
Methods | Prospective double‐blind randomised controlled trial |
Participants | Neonates with seizures, diagnosis based on clinical examination. Both full‐term neonates as well as preterm included. Exclusion criteria: acute electrolyte disturbance, inborn error of metabolism, opioid withdrawal syndrome, ASM given prior to inclusion 136 neonates screened, 104 included The study was performed in a tertiary care centre in Benha, Egypt, between March 2020 and March 2022. |
Interventions | Group A: Phenobarbital IV or orally, loading dose 20 mg/kg, second loading if not successful with 10 mg/kg. If successful, PB continued as maintenance (5 mg/kg*d). Add‐on of LEV if not successful after 40 min. Group B: Levetiracetam IV or orally, loading dose 20 mg/kg, second loading if not successful with 10 mg/kg. If successful, LEV continued as maintenance (20 mg/kg*d). Add‐on of PB if not successful after 40 min. |
Outcomes | Primary outcome: clinical cessation of seizures within 20/40 min of IV drug application and seizure‐free for the following 24 hrs. Secondary outcome: adverse events |
Notes | Demographic data and seizure aetiology show some differences between both groups (gestational diabetes mellitus, maternal hypertension, perinatal asphyxia). Seizure control (clinical impression) was better in the LEV group than in the PB group. Adverse events were more frequent in the PB group, including need for mechanical ventilation in 2/52. No information is given on EEG findings in participants. The authors reported no conflicting interests and no external funding for the research. |