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. 2024 Sep 19:11:1410571.
doi: 10.3389/fnut.2024.1410571. eCollection 2024.

The efficacy and safety of isotonic and hypotonic fluids in intravenous maintenance fluid therapy in term newborns: national multicenter observational "neofluid" study

Hasan Ozkan  1 , Nuray Duman  1 , Funda Tuzun  1 , Fatma Narter  2 , Can Akyildiz  1 , Emel Altuncu  2 , Mehmet Satar  3 , Mustafa Ozdemir  3 , Abdullah Kurt  4 , Ali U Tugcu  4 , Murat Konak  5 , Saime Sundus Uygun  5 , Seda Yilmaz Semerci  6 , Rahime T Dikmen  7 , Bora Baysal  8 , Cemile K Zeybek  8 , Yasemin Ezgi Kostekci  9 , Suzan Sahin  10 , Merve Tutal  11 , Ayse Anik  12 , Mehmet Buyuktiryaki  13 , Belma S Karagol  14 , Gaffari Tunç  15 , Derya Colak  16 , Hasan Cetin  17 , Aysen Orman  18 , Ozgur Olukman  19 , Mehmet Fatih Deveci  20 , Dilek Sarici  21 , Salih C Cakir  22 , Pembe Keskinoglu  1
Affiliations

The efficacy and safety of isotonic and hypotonic fluids in intravenous maintenance fluid therapy in term newborns: national multicenter observational "neofluid" study

Hasan Ozkan et al. Front Nutr. .

Abstract

Objective: The objective of this study was to evaluate the efficacy and safety of isotonic and hypotonic intravenous fluids in maintenance fluid therapy for term infants.

Methods: This was a multi-centre, prospective, observational study conducted in 21 participating centres from December 30, 2020, to June 30, 2023. The study included term newborns requiring parenteral fluid therapy for maintenance (NCT04781361). The fluid treatment was divided into two groups based on the concentration of sodium in the parenteral fluid, designated as hypotonic (NaCl <130 mmol/L) and isotonic (NaCl = 130-154 mmol/L). The primary outcomes were the change in mean plasma sodium (pNa) levels per hour (∆pNa mmol/L/h), the incidence of hyponatremia (pNa <135 mmol/L) and hypernatremia (pNa >145 mmol/L), and the occurrence of clinically significant changes in sodium levels (∆pNa >0.5 mmol/L/h).

Results: A total of 420 patients from 21 centers were included. The ∆pNa was negative in the hypotonic fluid group and positive in the isotonic fluid group, with a significant difference between the groups [respectively -0.07 ± 0.03 (95% CI: -0.13 to -0.02); 0.04 ± 0.03 (95%CI: -0.02 to 0.09), p = 0.04]. There was no difference between the groups in terms of the development of hypernatremia or a clinically meaningful pNa increase. The hypotonic fluid group had a higher incidence of hyponatremia and a clinically meaningful sodium decrease compared to the isotonic fluid group [7.9% vs. 1.2% (OR:6.5, p:0.03)] and [12.2% vs.4.2% (OR:2.9, p = 0.03)].

Conclusion: Contrary to current understanding, this large-scale study is the first to demonstrate that the use of hypotonic fluids in maintenance fluid therapy for newborns poses a risk of hyponatremia development, whereas isotonic fluid therapy appears safe.

Keywords: fluid therapy; hypernatremia; hyponatremia; hypotonic; isotonic; maintenance; newborn; tonicity.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Flow diagram. *Demographic data and treatment-related morbidities were evaluated in 420 patients. **As the primary evaluated outcome was the hourly change in plasma sodium level (∆pNa), cases without follow-up sodium levels were excluded from the primary outcome analysis.
Figure 2
Figure 2
Hourly change in plasma sodium level of patients receiving isotonic and hypotonic fluid.
See this image and copyright information in PMC

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