Department of Neonatology, Royal Oldham Hospital, Oldham, Greater Manchester, UK.
Department of Neonatology, Mehta Multispeciality Hospital Pvt Ltd, Chennai, India.
J Matern Fetal Neonatal Med. 2022 Dec;35(25):6338-6345. doi: 10.1080/14767058.2021.1911998. Epub 2021 Apr 20.
The use of hypotonic fluids as maintenance therapy in the neonatal population has been in practice for a long time, but there is a lack of evidence for the choice of this fluid in neonates. This study compared isotonic (sodium chloride, 0.9%, and dextrose, 5%) versus hypotonic (sodium chloride, 0.15%, and dextrose, 5%) intravenous fluid for maintenance fluid therapy in neonates more than or equal to 34 weeks of gestational age.
In this triple-blind randomized clinical trial, we recruited 60 neonates admitted to a neonatal intensive care unit of a tertiary care children's hospital from June 2017 through May 2018 with normal baseline serum sodium levels, anticipated to require intravenous maintenance fluids for 24 hours or longer (intention-to-treat analyses). Patients were randomized to receive isotonic or hypotonic intravenous fluid at maintenance rates for 72 hours. The primary outcome was the incidence of hyponatremia (defined as serum sodium <135mEq/L) at 24 hours in both groups. The secondary outcomes were incidence of hypernatremia at 24 hours (defined as serum sodium >145 mEq/L), the incidence of hypo and hypernatremia at 48 and 72 hours, mean serum sodium at 24, 48, and 72 hours, rate of change of serum sodium during the study period, mean serum osmolality at the end of the study period, the absolute difference in osmolality during the study period, the absolute difference in weight during the study period and edema during the study period.
Of 60 enrolled neonates, 31 received isotonic fluids and 29 received hypotonic fluids. Three patients in the hypotonic group developed hyponatremia and none in isotonic group at 24 h (RR = 0.13; 95% CI = 0.007 - 2.485; = .106). Fourteen neonates developed hypernatremia in the isotonic group and one in hypotonic group at 24 h (RR = 13.09; 95% CI = 1.83 - 93.4; = .0001).
Our study results do not support the hypothesis that isotonic fluid is superior to hypotonic fluid in reducing the proportion of neonates developing hyponatremia after 24 hours of intravenous fluid therapy. The proportion of neonates developing hypernatremia is significantly higher after using isotonic fluid for maintenance therapy. TRIAL REGISTRATION CTRI/2017/05/008585.
在新生儿人群中，使用低张液作为维持治疗已经有很长时间了，但对于新生儿选择这种液体缺乏证据。本研究比较了等张（氯化钠 0.9%，葡萄糖 5%）与低张（氯化钠 0.15%，葡萄糖 5%）静脉输液在胎龄大于或等于 34 周的新生儿中的维持液治疗效果。
在这项三盲随机临床试验中，我们招募了 2017 年 6 月至 2018 年 5 月期间在一家三级儿童医院新生儿重症监护病房入院的胎龄正常的 60 名新生儿，预计需要静脉维持液治疗 24 小时或更长时间（意向治疗分析）。患者被随机分为两组，以维持速度接受等张或低张静脉输液 72 小时。主要结局是两组 24 小时时低钠血症（定义为血清钠 <135mEq/L）的发生率。次要结局是 24 小时时高钠血症的发生率（定义为血清钠 >145 mEq/L），48 小时和 72 小时时低钠血症和高钠血症的发生率，24、48 和 72 小时时的平均血清钠水平，研究期间血清钠的变化率，研究结束时的平均血清渗透压，研究期间渗透压的绝对差异，研究期间体重的绝对差异和研究期间的水肿。
在纳入的 60 名新生儿中，31 名接受等张液，29 名接受低张液。低张组 3 例发生低钠血症，等张组无一例发生（RR = 0.13；95%CI = 0.007 - 2.485； = .106）。24 小时时，等张组 14 例发生高钠血症，低张组 1 例发生（RR = 13.09；95%CI = 1.83 - 93.4； = .0001）。
我们的研究结果不支持等张液在降低静脉输液治疗 24 小时后新生儿低钠血症发生率方面优于低张液的假设。等张液用于维持治疗时，新生儿发生高钠血症的比例明显更高。试验注册 CTRI/2017/05/008585。
