A study to control the effectiveness of two drugs, which are phenobarbitone (used for seizures in first 28 days of life) and levetiracetam ( new drug for seizures) in newborns who have seizures in the first 24 hours of life with delayed cry at birth.
Phase 1
- Conditions
- Health Condition 1: G998- Other specified disorders of nervous system in diseases classified elsewhere
- Registration Number
- CTRI/2020/04/024952
- Lead Sponsor
- Department of neonatology and pediatrics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Full termGestational age more than equal to 37 weeks
Birth weight more than or equal to2 kgs
Perinatal asphyxia defined as:APGAR score less than 5 at 5 minutes, Cord pH less than 7.0, Base deficit more than12 : in deliveries attended by the pediatrician at the hospital
,Delayed onset of cry after 3 min of birth in deliveries not attended by doctor or at home.
HIE with clinical seizures : onset within 24 hours of life
Inborn neonates admitted on day one of life
Exclusion Criteria
Anticonvulsant prior to admission
Neonatal seizures due to proven metabolic causes: hypoglycemia, hypocalcaemia, etc.
Neonates who are treated with therapeutic hypothermia
Serum creatinine levels > 1.5mg/dl
Gross congenital malformations
TORCH infections
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method