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Early withdrawal of phenobarbitone in Neonatal seizures

Early withdrawal of phenobarbitone and recurrence of neonatal seizures: A randomized, open-label trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/01/017313
Enrollment
200
Registered
2019-01-31
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: G988- Other disorders of nervous system

Interventions

Control Intervention1: No Phenobarbitone group: Phenobarbitone will be stopped after 12 hours of seizure free period. Control Intervention2: Phenobarbitone group: Pheobarbitone will be continued for n

Sponsors

PGIMER Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Neonate >=34weeks of gestation to <28days of postnatal period admitted with neonatal seizure.

Exclusion criteria

Exclusion criteria: Neonates on >=2 antiepileptic drugs HIE stage III Metabolic causes of seizures like hypocalcemia, hypoglycemia Intracranial bleed Neonates with brain infarct Major congenital malformation Suspected storage disorders Suspected IEM Suspected chromosomal anomalies Suspected intrauterine infections (IUI) Seizure recurrence within 12 hours of phenobarbitone loading >28 days of postnatal life

Design outcomes

Primary

MeasureTime frame
Seizure recurrence in two groups.Timepoint: Till discharge—

Secondary

MeasureTime frame
Duration of hospital stay Time to reach full enteral feeds Neurological status at discharge Mortality Timepoint: Till discharge—

Countries

India

Contacts

Public ContactSuresh Kumar

Department of Pediatrics, Advanced PEdiatric Center, PGIMER, Chandigarh, Sector 12

sureshangurana@gmail.com9855373969

Outcome results

None listed

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