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极早产儿出生7天后停止或逐渐降低暖箱湿度:一项随机临床试验

Ceasing or gradually reducing incubator humidity after 7 days for extremely preterm infants: a randomised clinical trial.

作者信息

Noreiks Gillion, August Deanne, Lai Melissa, Davies Mark W

机构信息

Grantley Stable Neonatal Unit (GSNU), Royal Brisbane and Women's Hospital, Herston, Brisbane, QLD, Australia.

School of Nursing, Midwifery and Social Work, University of Queensland, St. Lucia, Brisbane, QLD, Australia.

出版信息

Eur J Pediatr. 2024 Dec 6;184(1):66. doi: 10.1007/s00431-024-05893-w.

DOI:10.1007/s00431-024-05893-w
PMID:39641809
Abstract

UNLABELLED

The purpose of this study is to compare the effects of two different ways of stopping incubator humidification on episodes of hypothermia, hyperthermia, hyponatraemia, hypernatraemia, or skin injury. The design is a single site, two-armed, parallel, randomised, clinical trial conducted between April 2019 and March 2022. The setting was a quaternary referral and teaching hospital in Queensland, Australia. There were 140 extremely preterm infants, born < 28 weeks gestational age (GA). Intervention groups were (1) cease humidity: incubator humidification turned from 80% to off at 00.01am on day 8 of life (n = 70); or (2) gradually reduce humidity: incubator humidification reduced by 5% at 00:01 of each day from day 8 until ceased on day 14 (n = 70). The primary outcome was episodes of temperature instability: defined as either hypothermia < 36.5 °C or hyperthermia > 37.5 °C. Secondary outcomes included episodes of hyponatraemia: hypernatraemia or skin injury. One hundred forty infants were enrolled, 70 in each group. No statistically significant differences for any outcomes. Hyperthermia: 77% (n = 54) in the cease group and 73% (n = 51) in the gradual reduction group (P = 0.70). Hypothermia: 53% (n = 37) in the cease group and 37% (n = 26) in the gradual reduction group (P = 0.09). The number of hyponatraemic events was similar for both groups (P = 0.73), as for hypernatraemic events (P = 0.3). Skin injury in week 2 of life: 63% in the cease group and 67% in the gradual reduction group (P = 0.72).

CONCLUSIONS

Ceasing or gradually reducing incubator humidification after day 7 of life had no effect on the number of episodes of hypothermia or hyperthermia in this cohort of extremely preterm infants (EPTI). There was also no effect on the number of episodes of hyponatraemia or hypernatraemia.

TRIAL REGISTRATION

ANZCTR.org.au (Australia New Zealand Clinical Trials Registry). ACTRN 1261 9000 266167 Registered 21/2/2019.

WHAT IS KNOWN

• Incubator humidification is a widely accepted and routine practice in the management of EPTI as it influences transepidermal water loss (TEWL) and supports thermoregulation. However, weaning practices remain varied and inconsistent across the globe. • There remains a paucity of data to inform specific evidenced-based humidification practices.

WHAT IS NEW

• Ceasing or gradually reducing incubator humidification after 7 days had no effect on temperature stability, serum sodium levels, or frequency of skin injury in this cohort of EPTI between day 8 and day 14. • There is no apparent benefit in prolonging incubator humidity beyond day 7 of life in these EPTI.

摘要

未标注

本研究的目的是比较两种不同的停止培养箱加湿方式对体温过低、体温过高、低钠血症、高钠血症或皮肤损伤发作的影响。该设计为一项单中心、双臂、平行、随机临床试验,于2019年4月至2022年3月进行。研究地点是澳大利亚昆士兰州的一家四级转诊和教学医院。共有140例极早产儿,出生时胎龄小于28周(GA)。干预组为:(1)停止加湿:出生后第8天凌晨00:01,培养箱湿度从80%调至关闭(n = 70);或(2)逐渐降低湿度:从出生后第8天开始,每天凌晨00:01培养箱湿度降低5%,直至第14天停止(n = 70)。主要结局是体温不稳定发作:定义为体温过低<36.5°C或体温过高>37.5°C。次要结局包括低钠血症发作、高钠血症或皮肤损伤。共纳入140例婴儿,每组70例。任何结局均无统计学显著差异。体温过高:停止加湿组为77%(n = 54),逐渐降低湿度组为73%(n = 51)(P = 0.70)。体温过低:停止加湿组为53%(n = 37),逐渐降低湿度组为37%(n = 26)(P = 0.09)。两组低钠血症事件数量相似(P = 0.73),高钠血症事件数量也相似(P = 0.3)。出生后第2周的皮肤损伤:停止加湿组为63%,逐渐降低湿度组为67%(P = 0.72)。

结论

在这组极早产儿(EPTI)中,出生后第7天之后停止或逐渐降低培养箱湿度对体温过低或体温过高发作次数没有影响。对低钠血症或高钠血症发作次数也没有影响。

试验注册

ANZCTR.org.au(澳大利亚新西兰临床试验注册中心)。ACTRN 1261 9000 266167,于2019年2月21日注册。

已知信息

• 培养箱加湿在EPTI管理中是一种广泛接受的常规做法,因为它影响经皮水分丢失(TEWL)并支持体温调节。然而,全球范围内断奶做法仍然各不相同且不一致。• 仍然缺乏数据来为具体的循证加湿做法提供依据。

新发现

• 在这组EPTI中,出生后7天之后停止或逐渐降低培养箱湿度对出生后第8天至第14天期间的体温稳定性、血清钠水平或皮肤损伤频率没有影响。• 在这些EPTI中,出生后第7天之后延长培养箱湿度没有明显益处。

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Neonatology. 2023;120(3):295-307. doi: 10.1159/000529026. Epub 2023 Mar 17.
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Guidelines for Reporting Outcomes in Trial Reports: The CONSORT-Outcomes 2022 Extension.试验报告中结果报告指南:CONSORT-结果2022扩展版
JAMA. 2022 Dec 13;328(22):2252-2264. doi: 10.1001/jama.2022.21022.
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Humidification Practices of Extremely Preterm Neonates: A Clinical Survey.
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Hypernatremia in Newborns: A Practical Approach to Management.新生儿高钠血症:一种实用的管理方法。
Biomed Hub. 2022 May 19;7(2):55-69. doi: 10.1159/000524637. eCollection 2022 May-Aug.
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Evaluation of the consistency of neonatal skin injury assessment using clinical images and the metric and graduated colour tool.使用临床图像和度量及梯度颜色工具评估新生儿皮肤损伤评估的一致性。
J Tissue Viability. 2022 Aug;31(3):395-403. doi: 10.1016/j.jtv.2022.05.002. Epub 2022 May 20.
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