Jindal 2021.

Study characteristics
Methods	Randomised controlled trial
Participants	Inclusion criteria: neonates 34 weeks of gestation to < 28 days of postnatal period admitted with neonatal seizure Exclusion criteria: neonates on 2 antiseizure medication; HIE stage III; metabolic cause (hypocalcaemia, hypoglycaemia); intracranial bleeding, brain infarct; major congenital malformation suspected storage disorders, IEM, chromosomal anomalies, and IUI; seizure recurrence within 12 hours of phenobarbitone loading; < 34 weeks of gestation; and > 28 days of postnatal life The study was performed in a single neonatal unit at a tertiary care hospital in India between January 2019 and December 2019.
Interventions	After a loading dose of PB (20 mg/kg), neonates who remained seizure‐free for at least 12 hours were enrolled. Group A: PB withdrawal group: (quote:)"phenobarbitone maintenance was stopped" (no further details reported) Group B: PB continued group: (quote:)"PB maintenance was continued until discharge and further continuation was decided based on clinician’s discretion." (no further details reported) PB withdrawal group (n = 112) Male, n (%): 73 (65.2) Age (days), mean (SD): 6.5 (1.8) Gestation (weeks), mean (SD): 37.1 (2.5) Birth weight (grams), mean (SD): 2536 (560) Antenatal comorbidities PIH, n (%): 3 (2.7) PROM, n (%): 13 (11.6) Foetal distress, n (%): 25 (22.3) Mode of delivery NVD, n (%): 75 (67) LSCS, n (%): 36 (32.1) Instrumentation, n (%): 1 (0.9) Resuscitation details Delayed cry at birth, n (%): 55 (49.1) Needed resuscitation, n (%): 53 (47.3) Postnatal neurological abnormality, n (%): 50 (44.6) Weight for age AGA, n (%): 69 (61.6) SGA, n (%): 42 (37.5) LGA, n (%): 1 (0.9) Anthropometry at admission Weight (grams), mean (SD): 2529 (566) Length (cm), mean (SD): 49.1 (2.9) Head circumference (cm), mean (SD): 31.5 (1.7) Abnormal neurological examination, n (%): 71 (63.4) Bulging anterior fontanelle, n (%): 4 (3.6) Tone Increased, n (%): 6 (5.4) Decreased, n (%): 48 (42.9) Abnormal posture, n (%): 36 (32.1) Deep tendon reflexes Exaggerated, n (%): 4 (3.6) Absent, n (%): 51 (45.5) Abnormal primitive neonatal reflexes, n (%): 64 (57.1) Abnormal pupillary reactions, n (%): 19 (17.0) Abnormal respiratory system, n (%): 24 (21.4) Abnormal cardiovascular system, n (%): 3 (2.7) Abnormal abdomen examination, n (%): 5 (4.5) Seizure onset (day of life), mean (SD): 4.0 (1.4) Frequency of seizures (episodes/day), mean (SD): 2.9 (1.6) Seizure semiology Subtle, n (%): 23 (20.5) Focal tonic, n (%): 26 (23.2) Focal clonic, n (%): 26 (23.2) Generalised tonic, n (%): 35 (31.2) Myoclonic, n (%): 2 (1.8) Autonomic changes, n (%): 9 (8) Status epilepticus, n (%): 11 (9.8) Phenobarbitone continued group (n = 109) Male, n (%): 75 (68.8) Age (days), mean (SD): 7.8 (2.1) Gestation (weeks), mean (SD): 37.1 (2.8) Birth weight (grams), mean (SD): 2527 (568) Antenatal comorbidities PIH, n (%): 10 (9.2) PROM, n (%): 9 (7.3) Foetal distress, n (%): 19 (17.4) Mode of delivery NVD, n (%): 81 (74.3) LSCS, n (%): 28 (25.7) Instrumentation, n (%): 0 (0) Resuscitation details Delayed cry at birth, n (%): 44 (40.4) Needed resuscitation, n (%): 43 (39.4) Postnatal neurological abnormality, n (%): 39 (35.8) Weight for age AGA, n (%): 71 (65.1) SGA, n (%): 37 (33.9) LGA, n (%): 1 (0.9) Anthropometry at admission Weight (grams), mean (SD): 2502 (568) Length (cm), mean (SD): 49.0 (2.9) Head circumference (cm), mean (SD): 31.4 (1.6) Abnormal neurological examination, n (%): 69 (63.3) Tone Increased, n (%): 11 (10.1) Decreased, n (%): 42 (38.5) Abnormal posture, n (%): 33 (30.3) Deep tendon reflexes Exaggerated, n (%): 4 (3.7) Absent, n (%): 46 (42.2) Abnormal primitive neonatal reflexes, n (%): 62 (56.9) Abnormal pupillary reactions, n (%): 15 (13.8) Abnormal respiratory system, n (%): 22 (20.2) Abnormal cardiovascular system, n (%): 4 (3.7) Abnormal abdomen examination, n (%): 2 (1.8) Seizure onset (day of life), mean (SD): 5.6 (1.9) Frequency of seizures (episodes/day), mean (SD): 3.1 (1.5) Seizure semiology Subtle, n (%): 16 (14.7) Focal tonic, n (%): 15 (13.8) Focal clonic, n (%): 35 (32.1) Generalised tonic, n (%): 39 (35.8) Myoclonic, n (%): 4 (3.7) Autonomic changes, n (%): 10 (9.2) Status epilepticus, n (%): 13 (11.9)
Outcomes	Primary outcome: seizure recurrence Secondary outcomes: (quote:) "time to reach full enteral feeds, duration of hospital stay, neurological status at discharge, and mortality."
Notes	The diagnosis of seizure was made on the basis of history and clinical observation and all types of clinical seizures were included. The authors declared there was no external funding. The authors declared they had no competing financial interests or personal relationships that could have appeared to influence the work.