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

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.