Once or twice daily dose of phenobarbital to control seizure in neonates

The efficacy of intravenous phenobarbital as once or twice daily dose in neonates with seizure in NICU

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20090813002342N12

Enrollment

Registered

2020-12-31

Start date

2017-09-23

Completion date

Unknown

Last updated

2021-01-05

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

Conditions

Convulsions of newborn. Convulsions of newborn

Interventions

Intervention 1: Group 1 (once daily): Patients were received intravenous (IV) phenobarbital with an initial dose of 20 mg/kg and as needed with an increase of 10 mg/kg every 15 minutes to a maximum of

Eligibility

Sex/Gender

All

Age

1 Days to 28 Days

Inclusion criteria

Inclusion criteria: Newborns with seizures that use IV phenobarbital

Exclusion criteria

Exclusion criteria: Neonates with liver or kidney failure

Design outcomes

Primary

Measure	Time frame
Phenobarbital plasma concentration. Timepoint: Before starting the phenobarbital maintenance dose and at third day of maintenance therapy. Method of measurement: by High Performance Liquid Chromatography.	—

Secondary

Measure	Time frame
The numbers of new seizurs. Timepoint: During the study time for 5 days. Method of measurement: The visual report of responsible doctor or nurse.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammadreza Rafati

Mazandaran University of Medical Sciences

mrrafati@mazums.ac.ir+98 11 3354 3081

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026