The Comparative Clinical Trial of the Efficacy of Gabapentin vs. Phenobarbital in the Treatment of Neonatal Opioid Withdrawal Syndrome

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250815066860N1

Enrollment

Registered

2026-04-20

Start date

2025-03-21

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Neonatal Abstinence Syndrome. Newborn (suspected to be) affected by maternal use of other drugs of addiction

Interventions

Intervention 1: Neonates undergo serial assessments using the Finnegan Neonatal Abstinence Scoring Tool every 3-4 hours following birth. Infants exhibiting a Finnegan score exceeding 8 on three consec

Eligibility

Sex/Gender

All

Age

No minimum to 1 Months

Inclusion criteria

Inclusion criteria: Hospitalized infants diagnosed with neonatal withdrawal syndrome

Exclusion criteria

Exclusion criteria: Infants with major congenital anomalies infants who have other reasons for hospitalization infants whose parents did not consent to the study

Design outcomes

Primary

Measure	Time frame
Treatment duration,. Timepoint: Time to enter the study. Method of measurement: days.;Adjunt therapy with morphin. Timepoint: Time to enter the study. Method of measurement: recording.	—

Secondary

Measure	Time frame
Side effect. Timepoint: time to entry the study. Method of measurement: record.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNazanin Shahabinejad

Kerman University of Medical Sciences

nazaninshahabi1379@gmail.com+98 913 242 8232

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026