Efficacy Of Levetiracetam in the Treatment of Neonatal Seizures Presenting at Tertiary Care Hospital.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Seizure Cessation Within 40 Minutes
研究概览
简要总结
Neonatal seizures are a common neurological emergency in newborn babies and can lead to serious brain injury if not treated promptly. Phenobarbitone is commonly used as first-line treatment, but it is associated with delayed seizure control and adverse effects such as sedation and poor feeding.
This study was conducted to compare the effectiveness and safety of levetiracetam with conventional antiepileptic drugs (phenobarbitone with or without phenytoin) in the treatment of neonatal seizures.
In this randomized controlled trial, newborns aged 0 to 28 days diagnosed with seizures were randomly assigned to receive either intravenous levetiracetam or phenobarbitone-based therapy. The main outcomes assessed were seizure control within 40 minutes, seizure freedom at 24 and 48 hours, recurrence of seizures, time taken to control seizures, adverse effects, and mortality.
The results of this study aim to provide evidence on whether levetiracetam is a safer and more effective alternative for managing neonatal seizures in a tertiary care hospital setting.
详细描述
This study is a prospective, double-blinded, randomized controlled parallel-group trial conducted in the Neonatal Intensive Care Unit of the Department of Pediatrics, MTI District Head Quarter Hospital, Dera Ismail Khan. The study was carried out over a period of one year after approval from the Institutional Research and Ethics Board.
A total of 260 neonates aged 0 to 28 days with clinically diagnosed neonatal seizures were enrolled after obtaining written informed consent from parents or legal guardians. Neonates who were already receiving antiepileptic drugs or had congenital cardiac or renal diseases were excluded. Participants were randomly allocated into two equal groups using a table of random numbers with allocation concealment through sequentially numbered sealed opaque envelopes.
Group A received intravenous levetiracetam administered at a rate of 1 mg/kg/min, followed by a loading dose of 20 mg/kg diluted in normal saline. Maintenance therapy of 20 mg/kg/day was continued after seizure control. Group B received phenobarbitone as first-line therapy with a loading dose of 20 mg/kg followed by maintenance dosing. In cases of persistent seizures, phenytoin was added according to standard dosing protocols. No crossover between groups occurred.
The primary outcome was seizure cessation within 40 minutes of drug administration. Secondary outcomes included seizure freedom at 24 and 48 hours, recurrence of seizures, mean time to seizure control, adverse effects such as sedation, respiratory suppression, hypotension, and mortality. All patients were monitored in the neonatal intensive care unit for five days and followed for up to 14 weeks after discharge.
Data were analyzed using SPSS software. Outcomes were compared between groups to evaluate the efficacy and safety of levetiracetam compared with phenobarbitone-based therapy in the management of neonatal seizures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, treating clinicians, investigators, and outcome assessors were blinded to treatment allocation. Randomization was performed using sealed opaque envelopes to maintain allocation concealment.
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates (0-28 days old) with clinically diagnosed seizures.
- •Both term and preterm neonates.
- •Admitted to the neonatal intensive care unit (NICU) or pediatric ward.
- •Written informed consent obtained from parents or legal guardians.
排除标准
- •Neonates with major congenital anomalies or genetic syndromes.
- •Neonates with severe renal or hepatic impairment.
- •Neonates with metabolic disorders requiring specific treatment (e.g., hypoglycemia, hypocalcemia) unless seizures persist after correction.
- •Neonates already receiving anticonvulsant therapy prior to admission.
- •Neonates with confirmed meningitis or central nervous system infections requiring specific management (unless seizures persist after appropriate treatment).
- •Neonates with life-threatening conditions where study treatment cannot be safely administered.
- •Parents or legal guardians refusing consent.
研究组 & 干预措施
Levitiracetam Group
Neonates presenting with clinically diagnosed seizures will receive intravenous levetiracetam as the first-line anticonvulsant. Initial dose 20 mg/kg IV, followed by 20 mg/kg IV after 12 hours if seizures persist. Maintenance dose will be 10 mg/kg IV/PO twice daily as per hospital protocol. Seizure control and side effects will be monitored.
干预措施: Levetiracetam (Drug)
Phenobarbitone Group
Neonates with clinically diagnosed seizures received intravenous phenobarbitone as the first-line anticonvulsant with a loading dose of 20 mg/kg followed by maintenance dosing of 3-5 mg/kg/day. In cases of persistent seizures, phenytoin was added according to standard dosing protocols. Seizure response and adverse effects were monitored.
干预措施: Phenobarbital Sodium Injection (Drug)
结局指标
主要结局
Seizure Cessation Within 40 Minutes
时间窗: Immediately after first-line drug administration (within 40 minutes)
Proportion of neonates with clinically diagnosed seizures whose seizures stopped completely within 40 minutes after administration of the first-line anticonvulsant.
次要结局
- Time to Seizure Cessation(From first-line drug administration to seizure cessation (up to 40 minutes))
- Need for Second-Line Anticonvulsant(Immediately after first-line treatment failure (within 40 minutes of initial drug administration))
- Seizure Recurrence During Hospital Stay(From initial seizure control through 7 days of hospitalization)
- Incidence of Adverse Drug Reactions(From first drug administration through the first 5 days of hospitalization)
- Mortality(From enrollment through assessment at discharge, 28 days and 90days)
研究者
Gohar Ali
Trainee Registrar
Hayat Abad Medical Complex, Peshawar