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评价两种聚乙烯袋预防早产儿入院低体温的效果:一项半随机临床试验。

Evaluation of two polyethylene bags in preventing admission hypothermia in preterm infants: a quasi-randomized clinical trial.

机构信息

Universidade Estadual de Campinas (Unicamp), Hospital da Mulher Prof. Dr. José Aristodemo Pinotti, Divisão de Neonatologia, Campinas, SP, Brazil.

Universidade Estadual de Campinas (Unicamp), Hospital de Saúde da Mulher Prof. Dr. José Aristodemo Pinotti, Campinas, SP, Brazil.

出版信息

J Pediatr (Rio J). 2023 Sep-Oct;99(5):514-520. doi: 10.1016/j.jped.2023.04.004. Epub 2023 May 10.

Abstract

OBJECTIVE

To compare two polyethylene bags in preventing admission hypothermia in preterm infants born at <34 weeks gestation.

METHOD

Quasi-randomized unblinded clinical trial conducted at a level III neonatal unit between June 2018 to September 2019. The authors assign infants between 24 and 33 weeks' gestation to receive NeoHelp™ bag (intervention group) or a usual plastic bag (control group). The primary outcome was admission hypothermia, considering an axillary temperature at admission to the neonatal unit of <36.0 °C. Hyperthermia was considered if the admission temperature reached 37.5 °C or more.

RESULTS

The authors evaluated 171 preterm infants (76, intervention group; 95, control group). The rate of admission hypothermia was significantly lower in the intervention group (2.6% vs. 14.7%, p = 0.007), with an 86% reduction in the admission hypothermia rate (OR, 0.14; 95% CI, 0.03-0.64), particularly for infants weighing >1000 g and >28 weeks gestation. The intervention group also had a higher median of temperature at admission - 36.8 °C (interquartile range 36.5-37.1) vs. 36.5 °C (interquartile range 36.1-36.9 °C), p = 0.001, and showed a higher hyperthermia rate (9.2% vs. 1.0%, p = 0.023). Birth weight was also associated to the outcome, and it represented a 30% chance reduction for every 100-g increase (OR, 0.997; 95% CI, 0.996-0.999). The in-hospital mortality rate was similar between groups.

CONCLUSION

The intervention polyethylene bag was more effective in preventing admission hypothermia. Nonetheless, the risk of hyperthermia is a concern during its use.

摘要

目的

比较两种聚乙烯袋在预防<34 周胎龄早产儿入院低体温中的作用。

方法

2018 年 6 月至 2019 年 9 月在三级新生儿病房进行的半随机非盲临床试验。作者将 24 至 33 周龄的婴儿分配到接受 NeoHelp™袋(干预组)或常规塑料袋(对照组)。主要结局是入院低体温,即入院时腋温<36.0°C。如果入院时体温达到 37.5°C 或更高,则认为体温过高。

结果

作者评估了 171 例早产儿(干预组 76 例,对照组 95 例)。干预组的入院低体温发生率显著降低(2.6% vs. 14.7%,p=0.007),入院低体温发生率降低 86%(OR,0.14;95%CI,0.03-0.64),尤其是体重>1000 g 和>28 周胎龄的婴儿。干预组入院时的体温中位数也较高-36.8°C(四分位间距 36.5-37.1)vs. 36.5°C(四分位间距 36.1-36.9°C),p=0.001,且体温过高发生率较高(9.2% vs. 1.0%,p=0.023)。出生体重也与结局相关,每增加 100 g,发生低体温的可能性降低 30%(OR,0.997;95%CI,0.996-0.999)。两组的院内死亡率相似。

结论

干预用聚乙烯袋在预防入院低体温方面更有效。然而,在使用过程中体温过高的风险值得关注。

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