Comparison of the effect of phenobarbital and levetiracetam in the treatment of neonatal abstinence syndrome

Comparison of the effect of phenobarbital and levetiracetam in the treatment of neonatal abstinence syndrome as adjunctive therapy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20211218053444N2

Enrollment

Registered

2022-02-25

Start date

2022-04-21

Completion date

Unknown

Last updated

2022-03-08

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

Conditions

Neonatal abstinence syndrome. Neonatal withdrawal symptoms from maternal use of drugs of addiction

Interventions

Intervention 1: Intervention group: Neonates with neonatal abstinence syndrome underwent Adjunctive therapy with levetiracetam. Intervention 2: Control group: Neonates with neonatal abstinence syndr

Eligibility

Sex/Gender

All

Age

1 Days to 28 Days

Inclusion criteria

Inclusion criteria: Hospitalized neonates with a gestational age of 35 weeks and older with moderate to severe neonatal abstinence syndrome

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Jamali

Kerman University of Medical Sciences

z.jamali@kmu.ac.ir+98 34 3132 8000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 8, 2026