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

Not Applicable

• Conditions: neonatal seizures; Neurological - Epilepsy

• Registration Number: ACTRN12622000470796
• Lead Sponsor: DR KHWAJA KAMRAN WAJID

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-25
• Last Update Posted: 16 May 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 184

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
termination of seizures within 24 hours assessed by a physical examination conducted by a pediatrician.[continuous 24 hours monitoring post-intervention commencement];continuous monitoring for 5 days for terminations of seizures within 5 days assesses by physical examination conducted by a pediatrician post intervention commencement. <br>[ continuous physical monitoring 5 DAYS post intervention commencement .]

Secondary Outcome Measures

Name	Time	Method
<br>ADVERSE EFFECTS: Occurrence within two hours of drug administration, including desaturation, reduced respiratory rate, arrhythmias, blood pressure, or heart rate fluctuations by more than 10% compared to the previous 2 hours, or if vasopressors were initiated or increased, were recorded<br> CTCAE 5.0 GRADE 2.[continuous daily observation for 5 days post-intervention commencement]