A Clinical Study to compare Levetiracetam and Phenobarbitone in Newborns with Birth Asphyxia

Phase 4

Recruiting

Conditions: Levetiracetam in Perinatal Asphyxia

Registration Number: CTRI/2016/10/007412

Lead Sponsor: Sarojini Naidu Children Hospital

Brief Summary: This study is a single centre randomized, single blind, parallel group, active controlled trial comparing the efficacy and safety of Levetiracetam with Phenobarbitone in Neonates with Perinatal Asphyxia.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 60

Inclusion Criteria

Full term neonates (37 completed weeks to less than 42 weeks of gestational age) Less than 24 hours of age at presentation HIE stage II or III (as per Sarnat and Sarnat staging).

Exclusion Criteria

Neonates received at least one dose of anticonvulsants Severe congenital anomalies or CNS malformations Convulsions due to hypoglycemia/hypocalcemia Neonatal Sepsis Major intracranial hemorrhage Serum creatinine more than 0.8 mg/dl.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Control of Neonatal Seizures with first anticonvulsant	First week of life (Early Neonatal period)
Need of second anticonvulsant	First week of life (Early Neonatal period)
Neonatal Mortality during first week of life	First week of life (Early Neonatal period)
Neurological status at discharge	First week of life (Early Neonatal period)

Secondary Outcome Measures

Name	Time	Method
Safety profile of Levetiracetam	Duration of Hospital Stay

Trial Locations

Locations (1): Sarojini Naidu Children Hospital (SNCH)
🇮🇳
Allahabad, UTTAR PRADESH, India
Sarojini Naidu Children Hospital (SNCH)
🇮🇳Allahabad, UTTAR PRADESH, India
Dr Shahid Akhtar Siddiqui
Principal investigator
09559441844
sha.akht@gmail.com