Department of Pediatrics, School of Medicine, Afzalipour Hospital, Kerman University of Medical Sciences, Kerman, Iran.
Department of Pediatrics, School of Medicine; Clinical Research Development Unit, Afzalipour Hospital, Kerman University of Medical Sciences, Kerman, Iran.
BMC Pregnancy Childbirth. 2024 Apr 5;24(1):242. doi: 10.1186/s12884-024-06433-y.
Infants who are born from mothers with substance use disorder might suffer from neonatal abstinence syndrome (NAS) and need treatment with medicines. One of these medicines is phenobarbital, which may cause side effects in long-term consumption. Alternative drugs can be used to reduce these side effects. This study seeks the comparison of the effects of phenobarbital & levetiracetam as adjuvant therapy in neonatal abstinence syndrome.
This randomized clinical trial was performed in one year from May 2021 until May 2022. The neonates who were born from mothers with substance use disorder and had neonatal abstinence syndrome in Afzalipoor Hospital of Kerman were studied. The treatment started with morphine initially and every four hours the infants were checked. The infants who were diagnosed with uncontrolled symptoms After obtaining informed consent from the parents were randomly divided into two groups and treated with secondary drugs, either phenobarbital or levetiracetam.
Based on the obtained results, it was clear that there was no significant difference between the hospitalization time of the two infant groups under therapy (phenobarbital: 18.59 days versus Levetiracetam 18.24 days) (P-value = 0.512). Also, there was no significant difference between both groups in terms of the frequency of re-hospitalization during the first week after discharge, the occurrence of complications, and third treatment line prescription (P-value = 0.644).
Based on the obtained results, like hospitalization duration time (P-value = 0.512) it seems that levetiracetam can be used to substitute phenobarbital in treating neonatal abstinence syndrome.
The current study has been registered in the Iran registry of clinical trials website (fa.irct.ir) on the date 25/2/2022 with registration no. IRCT20211218053444N2.
患有物质使用障碍的母亲所生的婴儿可能患有新生儿戒断综合征（NAS），并需要用药物治疗。这些药物之一是苯巴比妥，长期使用可能会产生副作用。可以使用替代药物来减少这些副作用。本研究旨在比较苯巴比妥和左乙拉西坦作为新生儿戒断综合征辅助治疗的效果。
这是一项随机临床试验，于 2021 年 5 月至 2022 年 5 月进行了一年。研究对象为在克尔曼阿夫扎利普尔医院出生的患有物质使用障碍且患有新生儿戒断综合征的母亲所生的新生儿。治疗开始时先使用吗啡，每四小时检查一次婴儿。在获得父母的知情同意后，对诊断为症状控制不佳的婴儿进行随机分组，并使用辅助药物治疗，即苯巴比妥或左乙拉西坦。
根据所得结果，接受治疗的两组婴儿的住院时间（苯巴比妥：18.59 天与左乙拉西坦 18.24 天）（P 值=0.512）无显著差异。此外，两组在出院后第一周内再次住院的频率、并发症的发生以及三线治疗处方方面也无显著差异（P 值=0.644）。
根据所得结果，与住院时间（P 值=0.512）相似，左乙拉西坦似乎可以替代苯巴比妥治疗新生儿戒断综合征。
本研究已于 2022 年 2 月 25 日在伊朗临床试验注册网站（fa.irct.ir）注册，注册号为 IRCT20211218053444N2。
