Skip to content

EFFICACY AND SAFETY OF levetiracetam versus phenytoin for neonatal seizures.A randomized controlled trial.

Efficacy and safety of Levetricetam Versus Phenytoin for Neonatal Seizures: A Randomized Controlled Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000470796
Enrollment
184
Registered
2022-03-25
Start date
2022-05-12
Completion date
Unknown
Last updated
2022-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

"The rationale of this study is that neonatal seizure is a treatable condition and the present anticonvulsants used are not much efficient as well as not safe in neonates in controlling the seizures. Therefore, we want to compare the efficacy and adverse effects between both Phenytoin and Levetricetam which will help in finding the best drug controlling the neonatal seizures quickly with minimal adverse effects. We hypothesise that levetiracetam is more effective and safe than phenytoin in termination of seizures

Interventions

Participants will receive one loading dose levetiracetam of 5-10mg/kg intravenously over 15 minutes following identification of seizures. This maintenance dose 10mg/kg intravenously will be started 12 hours after the first loading dose The maintenance dose will be given once daily thereafter until termination of seizures."

Sponsors

DR KHWAJA KAMRAN WAJID
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
1 Hours to 30 Days
Healthy volunteers
No

Inclusion criteria

Neonates till 30 days of life both male/female with seizures.

Exclusion criteria

Neonates with hypoglycemia, hypocalcemia, hypomagnesemia, those who received anticonvulsants prior to enrolment, and those with major congenital malformations e.g., congenital heart defects, neural tube malformations, diaphragmatic hernia, choanal atresia, esophageal atresia, tracheoesophageal fistula, omphalocele, gastroschisis, intestinal obstruction and imperforate anus) were excluded.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026