Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Puducherry, 605006, India.
Department of Biochemistry, Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Puducherry, India.
Indian J Pediatr. 2023 Sep;90(9):886-892. doi: 10.1007/s12098-022-04289-8. Epub 2022 Jul 18.
To evaluate whether magnesium sulfate and therapeutic hypothermia in combination decreases mortality and/or major neurodevelopmental disability at 1 y of age among term neonates with hypoxic-ischemic encephalopathy.
A total of 134 term neonates were randomized to receive intravenous magnesium sulfate at a dose of 250 mg/kg (at 8 mg/kg/min) once daily for 3 d starting within 6 h after birth along with therapeutic hypothermia in the intervention group and therapeutic hypothermia alone in the comparator group. The primary outcome was the composite outcome of mortality and/or major neurodevelopmental disability (Developmental Assessment Scale for Indian Infants score < 70) at 1 y of age.
A total of 115 infants were included in the primary analysis. The composite primary outcome occurred in 14 (24%) infants in the intervention group and 19 (33%) infants in the comparator group, and the difference was not statistically significant (p = 0.30; relative risk 0.72; 95% confidence interval 0.40-1.30). The secondary outcomes including neonatal mortality, major neurodevelopmental disability at 1 y of age, neurological status at discharge, level of oxidative stress markers, and adverse effects including hypotension and respiratory depression requiring support were also comparable between the groups.
The combination of magnesium sulfate and therapeutic hypothermia did not improve the composite outcome of neonatal mortality and/or major neurodevelopmental disability at 1 y of age.
Clinical Trials Registry of India (CTRI/2018/06/014594), prospectively registered.
评估在出生后 6 小时内接受镁剂（250mg/kg，8mg/kg/min）单次静脉滴注，连用 3 天，联合亚低温治疗与单纯亚低温治疗，对伴有缺氧缺血性脑病的足月新生儿在 1 岁时的死亡率和/或主要神经发育障碍的影响。
共有 134 例足月新生儿被随机分为干预组（接受静脉滴注镁剂，剂量为 250mg/kg，8mg/kg/min，每天一次，连用 3 天，出生后 6 小时内开始）和对照组（仅接受亚低温治疗）。主要结局为 1 岁时的死亡率和/或主要神经发育障碍（印度婴儿发育评估量表评分<70）的复合结局。
共有 115 例婴儿纳入主要分析。干预组中有 14 例（24%）婴儿出现复合主要结局，对照组中有 19 例（33%）婴儿出现复合主要结局，差异无统计学意义（p=0.30；相对风险 0.72；95%置信区间 0.40-1.30）。次要结局，包括新生儿死亡率、1 岁时的主要神经发育障碍、出院时的神经状态、氧化应激标志物水平以及需要支持的低血压和呼吸抑制等不良反应，两组间也无差异。
镁剂联合亚低温治疗并未改善新生儿死亡率和/或 1 岁时主要神经发育障碍的复合结局。
印度临床试验注册中心（CTRI/2018/06/014594），前瞻性注册。
