levetiracetam used as first line anti epileptic versus phenobarbitone in neonatal convulsions

Not Applicable

Completed

• Conditions: Health Condition 1: null- Admitted in the NICU with convulsions, not with any life threatening illness/malformation as mentioned in exclusion criteriaHealth Condition 2: P00-P96- Certain conditions originating in the perinatal period

• Registration Number: CTRI/2018/04/013161
• Lead Sponsor: Indira Gandhi Institute Of Child Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-03-12
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Neonates with convulsions at admission and not loaded with any anticonvulsant outside

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Whether the presenting convulsion/episode of convulsions was terminated with the <br/ ><br>drug(s) used. <br/ ><br>(2) Whether convulsions recurred within 24 hours from termination of the presenting <br/ ><br>convulsion. <br/ ><br>(3) The need to use additional antiepileptic drugs to terminate the presenting convulsion. <br/ ><br>(4) Adverse drug reactions (ADR). <br/ ><br>1) Termination of seizures: defined as cessation of seizures 10/20min following <br/ ><br>administration of drugs LEV/PBTimepoint: 0 hours- At the time of convulsion till time of cessation <br/ ><br>At 24 hours to look for recurrence

Secondary Outcome Measures

Name	Time	Method
Absence of seizures in next 48 hours of administration of drugs <br/ ><br>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