title: 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.
  
  
  METHODS
  A double blind randomized controlled trial.
  
  
  METHODS
  Level II neonatal intensive care unit (NICU) of a teaching hospital in Northern India.
  
  
  METHODS
  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.
  
  
  METHODS
  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).
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Paediatrics, LLRM Medical College, Meerut, Uttar Pradesh, *Institute of Human Behaviour and Allied Sciences, New Delhi; and #All India Institute of Medical Sciences, New Delhi; India. Correspondence to: Dr Amit Upadhyay, Associate Professor and Head, Department of Paediatrics, LLRM Medical College, Meerut, Uttar Pradesh, India. au.llrm@gmail.com.
authors.forename: Pranjali
authors.initials: P
authors.lastname: Saxena
authors.forename: Abhishek
authors.initials: A
authors.lastname: Singh
authors.forename: Amit
authors.initials: A
authors.lastname: Upadhyay
authors.forename: Priyanka
authors.initials: P
authors.lastname: Gupta
authors.forename: Sangeeta
authors.initials: S
authors.lastname: Sharma
authors.forename: Sreenivas
authors.initials: S
authors.lastname: Vishnubatla
mesh_terms: D000927:Anticonvulsants / Q000008:administration & dosage* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007194:India; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000188:drug therapy* / Q000453:epidemiology; D053208:Kaplan-Meier Estimate; D008297:Male; D010634:Phenobarbital / Q000008:administration & dosage* / Q000627:therapeutic use; D010919:Placebos / Q000008:administration & dosage / Q000627:therapeutic use; D012640:Seizures / Q000188:drug therapy* / Q000453:epidemiology; D028761:Withholding Treatment
chemical_list: D000927:Anticonvulsants; D010919:Placebos; D010634:Phenobarbital