Effect of Withholding Phenobarbitone Maintenance in Neonatal Seizures: A Randomized Controlled Trial.

Abstract:

OBJECTIVE:To compare the effect of withholding maintenance phenobarbitone on breakthrough seizures. DESIGN:A double blind randomized controlled trial. SETTING:Level II neonatal intensive care unit (NICU) of a teaching hospital in Northern India. PARTICIPANTS:152 term and near term neonates (34 weeks of gestation age) with admission weight ≥2 kg with clinically apparent seizures who received intravenous (IV) loading dose of 20 mg/kg of phenobarbitone. INTERVENTIONS:After 12 hours of seizure free period of the initial loading dose of phenobarbitone, one group received IV maintenance therapy and other 'no maintenance' (saline as placebo). MAIN OUTCOME MEASURE:Breakthrough seizures from randomization till discharge. RESULTS:Baseline variables were comparable in the two groups. Breakthrough seizures occurred in 30 (40%) subjects in placebo group and 24 (31.2%) in phenobarbitone group with RR (95% CI) of 1.28 (0.83-1.97) (P=0.19). Seizure recurrence, re-hospitali-sation, mortality and abnormal neurological assessment until 3 months were comparable in the two groups (P>0.05). Babies in either group with breakthrough seizures were more likely to be neurologically abnormal at 1 month than babies who did not have breakthrough seizures, but this difference decreased by 3 months. CONCLUSION:In term and near-term neonates, those who respond to loading dose of phenobarbitone after a single seizure episode, withholding of phenobarbitone maintenance may not significantly increase the risk of breakthrough seizures.

journal_name

Indian Pediatr

journal_title

Indian pediatrics

authors

Saxena P,Singh A,Upadhyay A,Gupta P,Sharma S,Vishnubatla S

subject

Has Abstract

pub_date

2016-12-15 00:00:00

pages

1069-1073

issue

12

eissn

0019-6061

issn

0974-7559

pii

S097475591600025

journal_volume

53

pub_type

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