Health Condition 1: null- Admitted in the NICU with convulsions, not with any life threatening illness/malformation as mentioned in exclusion criteria Health Condition 2: P00-P96- Certain conditions originating in the perinatal period
Conditions
Interventions
Intervention1: Levetiracetam
Phenobarbitone: Intravenous Levetiracetam (LEV) 20mg/kg over 20 min was given to neonates who satisfy the inclusion criteria as first line anti epileptic drug. If there is
Sponsors
Indira Gandhi Institute Of Child Health
Eligibility
Inclusion criteria
Inclusion criteria: Neonates with convulsions at admission and not loaded with any anticonvulsant outside
Exclusion criteria
Exclusion criteria: Neonates with: 1) hypoglycemia 2) hypocalcaemia 3) hypomagnesemia Neonates who have received anticonvulsants outside prior to admission Neonates with life threatening conditions and severe congenital malformations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Whether the presenting convulsion/episode of convulsions was terminated with the drug(s) used. (2) Whether convulsions recurred within 24 hours from termination of the presenting convulsion. (3) The need to use additional antiepileptic drugs to terminate the presenting convulsion. (4) Adverse drug reactions (ADR). 1) Termination of seizures: defined as cessation of seizures 10/20min following administration of drugs LEV/PBTimepoint: 0 hours- At the time of convulsion till time of cessation At 24 hours to look for recurrence | — |
Secondary
| Measure | Time frame |
|---|---|
| Absence of seizures in next 48 hours of administration of drugs Adverse drug reactions observed for each drug during the studyTimepoint: At 48 hours from enrollment to look for any adverse drug reactions and cessation of convulsions | — |
Countries
India
Contacts
Public ContactAyesha Romana
Indira Gandhi Institute of Child Health
Outcome results
None listed