Comparison of the effect of phenobarbital and levetiracetam in the treatment of neonatal abstinence syndrome
Phase 3
- Conditions
- eonatal abstinence syndrome.Neonatal withdrawal symptoms from maternal use of drugs of addictionP96.1
- Registration Number
- IRCT20211218053444N2
- Lead Sponsor
- Kerman University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Hospitalized neonates with a gestational age of 35 weeks and older with moderate to severe neonatal abstinence syndrome
Exclusion Criteria
Infants under 35 weeks of gestation
Infants with intrauterine growth restriction
Infants with congenital major anomalies
Infants who have a cause other than neonatal abstinence syndrome for their hospitalization
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Infants with neonatal abstinence syndrome. Timepoint: 1,3,6,10,14. Method of measurement: Finnegan Scoring Criteria.;Response rate to adjuvant therapy with levotiracetam compared with phenobarbital. Timepoint: 1,3,6,10,14. Method of measurement: Finnegan Scoring Criteria.
- Secondary Outcome Measures
Name Time Method