Falsaperla 2019.
Study characteristics | |
Methods | Randomised controlled trial |
Participants | Inclusion criteria: (quote)"term neonates with seizures manifesting within the first 28 days of life." Exclusion criteria: (quote:)"Newborns with SE, GE, and seizures secondary to transient metabolic disorders, including hypoglycaemia and hypocalcaemia; neonates with a positive history for maternal drug ingestion; those who received more than one anticonvulsant medication; and those neonates in whom LEV was used as second‐line therapy" The study was performed at a single centre in Catania, Italy. Patients were recruited between February 2016 and February 2018. LEV group Number of patients: 15 Gestational age: 38.13 ± 1.24 Sex (F/M): 4/11 Prenatal anomalies: 40% APGAR score 1 min: 7 66 ± 1.29 APGAR score 5 min: 9 13 ± 1.12 Respiratory distress: 33.33% PB group Number of patients: 15 Gestational age: 38.33 ± 1.04 Sex (F/M): 8/7 Prenatal anomalies: 40% APGAR score 1 min: 8 66 ± 0 89 APGAR score 5 min: 9.03 ± 0.84 Respiratory distress: 40% |
Interventions | Intravenous PB, initial dose of 20 mg/kg, followed by a maintenance dose of oral PB at 5 mg/kg; Intravenous LEV, initial dose of 20 mg/kg, followed by a maintenance dose of oral LEV at 20 mg/kg, with gradually increasing doses up to 40 mg/kg twice daily in case of nonresponse at initial doses. Therapy was maintained for one month after the seizures resolved. |
Outcomes | Neurodevelopmental outcomes evaluated with HNNE at baseline and after 1 month of treatment. The assessment was made by trained neonatologists, who evaluated the following neurological items: (1) tone and posture, (2) tone patterns, (3) movements, (4) reflexes, (5) abnormal signs, and (6) orientation and behaviour. |
Notes | External funding sources were not mentioned. All authors reported not having potential conflicts of interest to disclose. |