Department of Pediatrics, Advanced Pediatric Centre, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.
Division of Pediatric Critical Care, Department of Pediatrics, Advanced Pediatric Centre, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.
Epilepsy Behav. 2021 Apr;117:107875. doi: 10.1016/j.yebeh.2021.107875. Epub 2021 Mar 8.
The long-term administration of phenobarbitone in neonates may be associated with adverse neurological outcome. The timing of stopping phenobarbitone maintenance after acute seizure control in neonates is a matter of debate.
To study the effect of early withdrawal of phenobarbitone on recurrence of neonatal seizures.
Open-label randomized controlled trial.
Outborn neonates (≥34 weeks of gestation to <28 days of postnatal period) with seizures (n = 221) admitted to Neonatal unit in Pediatric emergency of a tertiary care hospital in north India over 1 year.
After a loading dose of phenobarbitone (20 mg/kg), neonates who remained seizure free for at least 12 h were enrolled after written informed consent from parents, and randomized (computer generated block randomization) to 'phenobarbitone withdrawal group' (n = 112) where phenobarbitone maintenance was stopped and 'phenobarbitone continued group' (n = 109) where phenobarbitone maintenance was continued until discharge and further as per clinician's discretion.
The primary outcome was seizure recurrence until discharge and secondary outcomes were time to reach full enteral feeds, duration of hospital stay, abnormal neurological status at discharge, and mortality in two groups.
The baseline variables were comparable in 2 groups. The incidence of seizure recurrence was similar in the phenobarbitone withdrawal and phenobarbitone continued groups (50% vs. 37.6%, respectively, p = 0.078). Among secondary outcomes, the phenobarbitone withdrawal and continued groups had similar time to reach full enteral feeds (4.02 days vs. 4.2 days, p = 0.75), duration of hospital stay (6.3 days vs. 6.5 days, p = 0.23), abnormal neurological status at discharge (45.6% vs. 38%, p = 0.39), and mortality (11.6% vs. 8.3%, p = 0.50).
Early withdrawal of phenobarbitone in neonatal seizures does not lead to a significant increase in the rate of seizure recurrence.
长期给新生儿服用苯巴比妥可能会导致不良的神经学结局。在新生儿急性惊厥控制后停止苯巴比妥维持治疗的时间存在争议。
研究早期停用苯巴比妥对新生儿惊厥复发的影响。
开放标签随机对照试验。
在印度北部一家三级保健医院的儿科急诊室住院的、胎龄≥34 周至出生后 28 天内的有惊厥发作的（n=221）的外出新生儿。
在给予负荷剂量苯巴比妥（20mg/kg）后，在父母书面知情同意后，对至少 12 小时无惊厥发作的新生儿进行入组，并进行随机分组（计算机生成的区组随机分组）：“苯巴比妥停药组”（n=112），停止苯巴比妥维持治疗；“苯巴比妥继续组”（n=109），继续苯巴比妥维持治疗，直至出院，并根据临床医生的判断进一步治疗。
主要结局是出院前的惊厥复发，次要结局是达到完全肠内喂养的时间、住院时间、出院时的神经状态异常和两组的死亡率。
两组的基线变量相似。苯巴比妥停药组和苯巴比妥继续组的惊厥复发发生率相似（分别为 50%和 37.6%，p=0.078）。在次要结局方面，苯巴比妥停药组和继续组达到完全肠内喂养的时间相似（分别为 4.02 天和 4.2 天，p=0.75），住院时间相似（分别为 6.3 天和 6.5 天，p=0.23），出院时神经状态异常相似（分别为 45.6%和 38%，p=0.39），死亡率相似（分别为 11.6%和 8.3%，p=0.50）。
新生儿惊厥发作时早期停用苯巴比妥不会显著增加惊厥复发率。
