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静脉补液在早产儿重度非结合胆红素血症管理中的应用——一项随机对照试验

Intravenous fluid supplementation in management of severe unconjugated hyperbilirubinemia in preterm neonates-a randomized controlled trial.

作者信息

Panda Santosh Kumar, Jena Pravati, Nayak Manas Kumar, Biswal Sebaranjan, Sahoo Manaswinee, Gudu Ramakrushna, Rath Soumini

机构信息

Department of Paediatrics, Kalinga Institute of Medical Sciences, KIIT DU, Bhubaneswar, Odisha, India.

Department of Neonatology, Kalinga Institute of Medical Sciences, KIIT DU, Bhubaneswar, Odisha, 751024, India.

出版信息

Eur J Pediatr. 2025 Jun 2;184(6):383. doi: 10.1007/s00431-025-06226-1.

Abstract

UNLABELLED

The purpose of this study is to evaluate the role of intravenous fluid supplementation in reducing total serum bilirubin (TSB) in preterm neonates with hyperbilirubinemia. In this open-label randomized control trial, a total of 72 preterm neonates with a gestational age of 29-33 weeks and a TSB level exceeding 2 mg/dl below the exchange transfusion threshold as per United Kingdom National Institute for Health and Care Excellence (UK-NICE) guidelines were randomized into the fluid supplementation (FS) group and the control group in a ratio of 1:1. Neonates in the FS group received intravenous fluid (5% dextrose on day 2 or N/5 saline with 5% dextrose, amount: 1/4th of total daily fluid intake or maximum 30 ml/kg over 8 h) with phototherapy vs. only phototherapy in the control group. The primary outcome was reduction in TSB level at 6, 18, and 24 h after intervention and duration of phototherapy in FS compared to the control group. The demographic characteristics and mean (SD) TSB levels of enrolled preterm neonates in both groups were comparable. The mean (SD) reduction in TSB level at 6 h in the FS group and the control group were 1.42 (1.19) and 0.32 (0.17), P = 0.001; at 18 h, 2.11 (1.35) and 0.79 (0.25), P = 0.001; and at 24 h, 2.96 (1.41) and 1.56 (0.46), P = 0.001. There was no significant difference in the duration of phototherapy [mean (SD) 44.66(5.45) vs 43.33 (5.93) h, P = 0.32] and cases of hyponatremia [14 (40%) vs 09 (24.3%) P = 0.153] at 24 h between FS and control group.

CONCLUSION

Intravenous fluid supplementation helps in the rapid reduction of TSB levels in preterm neonates with severe hyperbilirubinemia with minimal adverse effects, but does not affect the duration of phototherapy.

WHAT IS KNOWN

• Extra fluid supplementation has been found helpful in declining total serum bilirubin levels in late preterm and term neonates.

WHAT IS NEW

• Extra intravenous fluid supplementation may help in the rapid decline in total serum bilirubin in preterm neonates born with a gestational age of 29-33 weeks. • It may be used in the management of severe hyperbilirubinemia in preterm neonates with intensive phototherapy.

TRIAL REGISTRATION

Clinical trials registry of India, number-CTRI/2024/01/061381 dated on 04.01.2024.

摘要

未标注

本研究的目的是评估静脉补液在降低高胆红素血症早产儿总血清胆红素(TSB)水平方面的作用。在这项开放标签随机对照试验中,根据英国国家卫生与临床优化研究所(UK-NICE)指南,共有72例胎龄为29至33周、TSB水平超过2mg/dl且低于换血阈值的早产儿,按1:1的比例随机分为补液(FS)组和对照组。FS组新生儿接受静脉补液(第2天给予5%葡萄糖或含5%葡萄糖的1/5生理盐水,量为每日总液体摄入量的1/4或8小时内最大30ml/kg)并接受光疗,而对照组仅接受光疗。主要结局是干预后6、18和24小时TSB水平的降低以及FS组与对照组相比光疗的持续时间。两组纳入的早产儿的人口统计学特征和平均(标准差)TSB水平具有可比性。FS组和对照组在6小时时TSB水平的平均(标准差)降低分别为1.42(1.19)和0.32(0.17),P = 0.001;在18小时时,分别为2.11(1.35)和0.79(0.25),P = 0.001;在24小时时,分别为2.96(1.41)和1.56(0.46),P = 0.001。FS组和对照组在24小时时光疗持续时间[平均(标准差)44.66(5.45) 小时对43.33 (5.93) 小时,P = 0.

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