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一项比较极早产儿单纯从持续气道正压通气(CPAP)撤机与使用温热湿化高流量鼻导管撤机的随机试验:CHiPS研究。

A randomised trial comparing weaning from CPAP alone with weaning using heated humidified high flow nasal cannula in very preterm infants: the CHiPS study.

作者信息

Clements Joanne, Christensen Pernille M, Meyer Michael

机构信息

Neonatal Unit, Middlemore Hospital, Counties Manukau DHB, Auckland, New Zealand

Research & Evaluation Office, KoAwatea, Counties Manukau DHB, Auckland, New Zealand.

出版信息

Arch Dis Child Fetal Neonatal Ed. 2022 Jul 18;108(1):63-8. doi: 10.1136/archdischild-2021-323636.

Abstract

OBJECTIVE

To determine whether weaning from nasal continuous positive airway pressure (nCPAP) using heated humidified high flow nasal cannula (nHF) was non-inferior to weaning using nCPAP alone in relation to time on respiratory support.

STUDY DESIGN

Single-centre, non-inferiority, randomised controlled trial.

SETTING

Neonatal Intensive Care Unit, Middlemore Hospital, Auckland, New Zealand.

PATIENTS

120 preterm infants, <30 weeks' gestation at birth, stable on nCPAP for at least 48 hours.

INTERVENTIONS

Infants underwent stratified randomisation to nHF 6 L/min or bubble CPAP 6 cm water. In both groups, stepwise weaning of their respiratory support over 96 hours according to a strict weaning protocol was carried out.

MAIN OUTCOME MEASURES

Time on respiratory support from randomisation to 72 hours off respiratory support or 36 weeks' postmenstrual age. The non-inferiority threshold was set at 15%.

RESULTS

59 infants were randomised to weaning using nHF and 61 using nCPAP. The groups were well balanced in regards to baseline demographics. The restricted mean duration of respiratory support following randomisation for the nCPAP group, using per-protocol analysis was 401 hours (upper boundary, mean plus 0.15, was 461 hours) and 375 hours in the nHF group (upper 95% CI 413 hours). nHF weaning was, therefore, non-inferior to nCPAP weaning at the non-inferiority threshold. There was no significant difference in time to discharge.

CONCLUSION

For infants ready to wean from nCPAP, the CHiPS study found that nHF was non-inferior to discontinuing nCPAP at 5 cm water.

TRIAL REGISTRATION NUMBER

Australia and New Zealand Clinical Trials Registry (ACTRN12615000077561).

摘要

目的

确定在呼吸支持时间方面,使用加热湿化高流量鼻导管(nHF)从鼻持续气道正压通气(nCPAP)撤机是否不劣于单纯使用nCPAP撤机。

研究设计

单中心、非劣效性、随机对照试验。

研究地点

新西兰奥克兰米德尔莫尔医院新生儿重症监护病房。

研究对象

120例早产儿,出生时孕周<30周,使用nCPAP至少48小时且病情稳定。

干预措施

婴儿分层随机分为nHF 6 L/分钟组或气泡式CPAP 6厘米水柱组。两组均按照严格的撤机方案在96小时内逐步撤机。

主要观察指标

从随机分组至停止呼吸支持72小时或月经后年龄36周的呼吸支持时间。非劣效性界值设定为15%。

结果

59例婴儿随机分组至使用nHF撤机组,61例使用nCPAP撤机组。两组在基线人口统计学特征方面平衡良好。采用符合方案分析,nCPAP组随机分组后呼吸支持的受限平均持续时间为401小时(上限,均值加0.15,为461小时),nHF组为375小时(95%CI上限413小时)。因此,在非劣效性界值下,nHF撤机不劣于nCPAP撤机。出院时间无显著差异。

结论

对于准备从nCPAP撤机的婴儿,CHiPS研究发现nHF不劣于停止使用5厘米水柱的nCPAP。

试验注册号

澳大利亚和新西兰临床试验注册中心(ACTRN12615000077561)

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cf3b/9763181/84b55a77dbee/fetalneonatal-2021-323636f01.jpg

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