Saxena 2016.

Study characteristics
Methods	Randomised controlled trial
Participants	Inclusion criteria: (quote:) "term or near‐term neonates of ≥ 34 weeks of gestation up to 4 weeks postnatal age and weighing ≥ 2 kg. All types of clinical seizures were included in the study. The diagnosis of seizure was based on clinical observation only." Exclusion criteria: (quote:) "recurrence of seizures within 12 hrs of the loading dose of phenobarbitone, major congenital malformations, suspected storage disease (ruled out by metabolic screen), intrauterine infection (ruled out by serological screen) and suspected chromosomal abnormalities (based on facial dysmorphism and other phenotypic abnormalities)" Placebo group, 75 patients Weight (g), mean (SD): 2677 (448.7) Gestation (w), mean (SD): 37 (1.3) Male, n (%): 41 (54.7) Intramural delivery, n(%): 28 (37.3) Age at admission (h), median (IQR): 4 (0‐28) Onset of convulsion (h), median (IQR): 12 (5‐42.5) HIE (at admission) Stage I, n (%): 1 (1.3) Stage II 49, n (%): (65.3) Stage III 14, n (%): (18.7) Serum PB level(μg/mL) at 12 hours, mean (SD): 24.8 (23.4) Aetiology Birth asphyxia, n (%): 65 (86.7) Meningitis/sepsis, n (%): 6 (8) Metabolic, n (%): 2 (2.7) Intracranial haemorrhage, n (%): 2 (2.7) PB group, 77 patients Weight (g), mean (SD): 2742 (342.7) Gestation (w), mean (SD): 38 (1.4) Male, n(%): 50 (64.9) Intramural delivery, n (%): 27 (35.0) Age at admission (h), median (IQR): 3 (0‐16) Onset of convulsion (h), median (IQR): 12 (4‐24) HIE (at admission) Stage I, n (%): 4 (5.2) Stage II, n (%): 52 (68.8) Stage III, n (%): 9 (11.7) Serum PB level (μg/mL) at 12 hours, mean (SD): 20.2 (22.0) Aetiology Birth asphyxia, n (%): 69 (89.6) Meningitis/sepsis, n (%): 7 (9.1) Metabolic, n (%): 1 (1.3) Intracranial haemorrhage, n (%): 0 The study was conducted at a level II neonatal intensive care unit in India from September 2012 to September 2013.
Interventions	Initial correction of hypoglycaemia and hypocalcaemia, followed by load with intravenous PB at 20 mg/kg in 1:10 dilution with normal saline (NS) over a 15‐20‐minute period at a rate of 1 mg/kg/min. All responders (subjects who remained seizure‐free for a period of 12 hours after loading dose) were randomised into 2 groups. PB (200 mg/mL) was diluted 1:20 in NS (1 mL PB + 19 mL NS) to make its concentration 200 mg/20 mL or 10 mg/ mL. Maintenance dose was 2.5 mg/kg (of PB) which was equivalent to 0.25 mL/kg/dose of prepared solution every 12 hourly for 5 days. Placebo was 20 mL of normal saline kept in an identical syringe. Maintenance dose was equivalent to 0.25 mL/kg/dose of prepared solution every 12 hourly for 5 days. The study intervention stopped after 5 days of seizure‐free period. If a breakthrough seizure occurred, the baby was reloaded with 10 mg/kg of PB and put on open‐label maintenance of PB till discharge.
Outcomes	Seizure recurrence, mortality, need for inotropic support, time to reach full oral enteral nutrition, duration of hospital stay, neurodevelopment status, seizure recurrence and re‐hospitalisation up to 3 months of age.
Notes	The study was partially funded by 'Thesis/‐Research grant' of the Indian Council for Medical Research (ICMR). The authors reported not having potential conflicts of interest to disclose.