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+6 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. <Table Float="No" ID="Taba"> <tgroup cols="2"> <colspec align="left" colname="c1" colnum="1" /> <colspec align="left" colname="c2" colnum="2" /> <tbody> <row> <entry nameend="c2" namest="c1"> What is Known: • Extra fluid supplementation has been found helpful in declining total serum bilirubin levels in late preterm and term neonates. </entry> </row> <row> <entry nameend="c2" namest="c1"> 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+6 weeks. • It may be used in the management of severe hyperbilirubinemia in preterm neonates with intensive phototherapy. </entry> </row> </tbody> </tgroup> </Table>Trial registration: Clinical trials registry of India, number—CTRI/2024/01/061381 dated on 04.01.2024.

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

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发表日期：

2025年6月2日

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

摘要

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⁺⁶ 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⁺⁶ 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.