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延迟早产儿首次沐浴对皮肤屏障功能影响的多中心、单盲 RCT 研究方案。

The effect of delaying first bathing on skin barrier function in late preterm infants: A study protocol for multi-centre, single-blind RCT.

机构信息

Child Health Nursing Department, Nursing Faculty, Akdeniz University, Antalya, Turkey.

出版信息

J Adv Nurs. 2021 Feb;77(2):1051-1061. doi: 10.1111/jan.14657. Epub 2020 Nov 18.

Abstract

AIMS

The study aims to examine the effect of delaying first bathing on skin barrier function, body temperature, and neonatal comfort of late preterm infants.

DESIGN

This study is a multi-centre, single-blind, prospective randomized controlled trial.

METHODS

We attempt to report this randomized controlled trial to comply with the SPIRIT. The study population will consist of 80 late preterm infants born at three centres (hospitals) in Turkey. The study, between September 2020-September 2021 will be held in the Neonatal Intensive Care Unit. The participants will be randomly divided into two groups, each with different bathing times. The first group (N = 40) will be bathed between 24-48 hr after birth and the second group (N = 40) will be bathed between 48-72 hr after birth. Each group's intervention will be performed by a blinded researcher. The infants' transepidermal water loss, body temperature, and comfort level will be measured before the bath and again at three times after the bath. The measurements will be taken by a blinded researcher and blinded nurse.

DISCUSSION

The benefits of infant bathing are known. However, the effect of delaying first bathing of late preterm infants on skin barrier function is unknown. At the same time, the effect of delaying bathing on maintaining body temperature and neonatal comfort is unknown.

IMPACT

This study is expected to provide a piece of credible evidence of the delay of first bathing and benefit of neonatal care in this population. It is thought that postponing bathing time of late preterm infants to 48-72 hr after birth will lead to a protective effect on skin barrier and temperature. It will be performed in clinical practice if it can effectively improve transepidermal water loss and heat loss.

TRIAL REGISTRATION

It was registered at ClinicalTrials.gov in January 2020 (NCT04231799).

摘要

目的

本研究旨在探讨延迟首次沐浴对晚期早产儿皮肤屏障功能、体温和新生儿舒适度的影响。

设计

这是一项多中心、单盲、前瞻性随机对照试验。

方法

我们试图按照 SPIRIT 报告这项随机对照试验。研究人群将包括土耳其 3 个中心(医院)出生的 80 例晚期早产儿。该研究于 2020 年 9 月至 2021 年 9 月在新生儿重症监护病房进行。将参与者随机分为两组,每组沐浴时间不同。第一组(N=40)将在出生后 24-48 小时内沐浴,第二组(N=40)将在出生后 48-72 小时内沐浴。每个组的干预措施将由一名盲法研究人员进行。在沐浴前和沐浴后 3 次测量婴儿的经皮水分丢失、体温和舒适度。测量由盲法研究人员和盲法护士进行。

讨论

婴儿沐浴的益处是已知的。然而,延迟晚期早产儿首次沐浴对皮肤屏障功能的影响尚不清楚。同时,延迟沐浴对维持体温和新生儿舒适度的影响也不清楚。

影响

这项研究有望为该人群中延迟首次沐浴和新生儿护理的益处提供可信的证据。人们认为,将晚期早产儿的首次沐浴时间推迟到出生后 48-72 小时,可以对皮肤屏障和体温产生保护作用。如果能有效减少经皮水分丢失和热量丢失,将在临床实践中实施。

试验注册

该研究于 2020 年 1 月在 ClinicalTrials.gov 注册(NCT04231799)。

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