title: High dose (4 mg/kg/day) versus usual dose (2 mg/kg/day) oral prednisolone for treatment of infantile spasms: an open-label, randomized controlled trial.
abstract: OBJECTIVE
  This study aimed to test the hypothesis that high-dose prednisolone (4 mg/kg/day) may be more efficacious than usual-dose (2 mg/kg/day) prednisolone for spasm resolution at 14-days in children with infantile spasms.
  
  
  METHODS
  This was a randomized, open-label-trial conducted at a tertiary-level-hospital from February-2012 to March-2013. Children aged 3-months to 2-years presenting with infantile spasms in clusters (at least 1 cluster/day) with hypsarrhythmia or its variants on EEG were enrolled. The study participants were randomized to receive either high-dose prednisolone (4 mg/kg/day) or the usual-dose (2 mg/kg/day) prednisolone. The primary outcome measure was the proportion of children who achieved spasm freedom for 48-h at day-14 after treatment initiation as per parental reports in both the groups. The adverse effects were also monitored. The study was registered with the clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT01575639).
  
  
  RESULTS
  Sixty-three children were randomized into the two groups with comparable baseline characteristics. The proportion of children with spasm cessation on day-14 was significantly higher in the high-dose group as compared to the usual-dose group (51.6% vs. 25%, p=0.03). The absolute risk reduction was 26.6% (95% confidence interval 11.5-41.7%) with number needed to treat being 4. The adverse effects were comparable in both the groups.
  
  
  CONCLUSIONS
  High-dose prednisolone (4 mg/kg/d) was more effective than low-dose prednisolone (2mg/kg/d) in achieving spasm cessation at 14-days (as per parental reports) in children with infantile spasms.
authors.affiliation: Department of Pediatrics, Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital, New Delhi 110001, India. Electronic address: drprabac@gmail.com.
authors.forename: Prabaharan
authors.initials: P
authors.lastname: Chellamuthu
authors.affiliation: Division of Pediatric Neurology, Department of Pediatrics, Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital, New Delhi 110001, India. Electronic address: sharma.suvasini@gmail.com.
authors.forename: Suvasini
authors.initials: S
authors.lastname: Sharma
authors.affiliation: Division of Pediatric Neurology, Department of Pediatrics, Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital, New Delhi 110001, India; Division of Pediatric Neurology, Department of Pediatrics, BLK Super Speciality Hospital, Pusa Road, New Delhi 110005, India. Electronic address: puneet_mpa@yahoo.com.
authors.forename: Puneet
authors.initials: P
authors.lastname: Jain
authors.affiliation: Division of Pediatric Neurology, Department of Pediatrics, Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital, New Delhi 110001, India. Electronic address: jayashankarkaushik@gmail.com.
authors.forename: Jaya Shankar
authors.initials: JS
authors.lastname: Kaushik
authors.affiliation: Department of Pediatrics, Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital, New Delhi 110001, India. Electronic address: anjuseth.peds@gmail.com.
authors.forename: Anju
authors.initials: A
authors.lastname: Seth
authors.affiliation: Division of Pediatric Neurology, Department of Pediatrics, Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital, New Delhi 110001, India. Electronic address: sharma.suvasini@gmail.com.
authors.forename: Satinder
authors.initials: S
authors.lastname: Aneja
mesh_terms: D000284:Administration, Oral; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D008297:Male; D011239:Prednisolone / Q000008:administration & dosage*; D013036:Spasms, Infantile / Q000175:diagnosis* / Q000188:drug therapy* / Q000503:physiopathology; D016896:Treatment Outcome
chemical_list: D011239:Prednisolone
keywords: Hypsarrhythmia; Infantile spasms; Prednisolone; Randomized controlled trial