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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.
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OBJECTIVE: Caffeine treatment is routinely used in premature infants to prevent development of apnea and bronchopulmonary dysplasia. Although a limited number of studies have reported that early caffeine treatment may cause development of necrotizing enterocolitis (NEC) by reducing mesenteric blood flow, this issue is still under discussion. The aim of this study is to investigate the possible effect of different onset times of early caffeine treatment on mesenteric tissue oxygen saturation and NEC development in premature infants. STUDY DESIGN: A total of 87 preterm infants with ≤1,250-g birth weight (BW) was included in this prospective study. The cases were randomized as group 1 (first 24 hours) and group 2 (72nd hour) caffeine treatment groups and monitored by near-infrared spectroscopy (NIRS) for 72 hours from the time of admission until cerebral, renal, and mesenteric tissue oxygen saturations (rSO2) were recorded. The cases were followed-up to the 40th week in terms of NEC and other neonatal morbidities. RESULTS: A total of 87 infants were included in the study, including 45 in group 1 and 42 in group 2. The groups were similar in terms of demographic characteristics. The incidence of NEC in group 1 (20%) was higher in comparison to group 2 (9%). The mesenteric rSO2 values in the first 72 hours of group 1 were lower than those of group 2. Low gestational week, BW, and late onset of enteral feeding were found to be other significant risk factors for NEC. CONCLUSION: In this study, mesenteric tissue oxygenation was lower, and NEC was higher in group 1. Mesenteric rSO2 measurements may be useful in predicting the development of NEC in patients receiving early caffeine therapy. KEY POINTS: · Onset time of early caffeine treatment may effect on mesenteric tissue oxygen saturation.. · Caffeine treatment that onset in the first 24 hours may be associated with NEC development.. · Mesenteric rSO2 measurements may be useful in patients receiving early caffeine therapy..