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早产儿肺功能和支气管肺发育不良的体位管理:一项随机对照试验的研究方案。

Position management on pulmonary function and bronchopulmonary dysplasia in premature infants: study protocol for a randomised controlled trial.

机构信息

School of Nursing, Southwest Medical University, Luzhou, Sichuan, China.

Department of Pediatrics, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, China.

出版信息

BMJ Open. 2022 Dec 15;12(12):e062291. doi: 10.1136/bmjopen-2022-062291.

Abstract

INTRODUCTION

Bronchopulmonary dysplasia (BPD) is a common disease caused by various factors and mechanisms in premature infants. Owing to lung hypoplasia and the lack of alveolar surfactants in premature infants, oxygen therapy is often needed to maintain adequate breathing. Nevertheless, prolonged oxygen therapy can easily induce BPD, and there is currently no effective treatment. Therefore, the prevention of BPD in premature infants during hospitalisation is essential. Studies have revealed that the prone position can effectively improve the oxygenation of premature infants. However, a few studies have reported whether prone positioning can improve lung function and reduce BPD incidence. This trial will determine whether the prone position, compared with the supine position, can reduce BPD incidence and improve lung function in preterm infants.

METHODS AND ANALYSIS

This study protocol is for a single-centre, single-blind, randomised controlled trial of the prone position in premature infants. Following daily feeding, premature infants will be placed in the lateral position for 30 min; then they will be turned to the supine position (control group) or prone position (intervention group) for 2 hours each in the morning and afternoon. Moreover, infants in both groups will be placed in the supine or lateral position alternately according to their medical needs for the remaining time. The study begins when the premature infants are stable within 5 days after admission and ends when they are discharged from the hospital or at 36 weeks postmenstrual age. The primary outcome is the survival rate without BPD. The secondary outcomes include lung function parameters and lung oxygen saturation.

ETHICS AND DISSEMINATION

This trial is approved by the ethics committee of the Affiliated Hospital of Southwest Medical University, (ref approval no.KY2021186). The results will be published in a peer-reviewed journal.

TRIAL REGISTRATION NUMBER

ChiCTR2100049847.

摘要

介绍

支气管肺发育不良(BPD)是一种由早产儿多种因素和机制引起的常见疾病。由于早产儿肺发育不全和缺乏肺泡表面活性剂,通常需要氧疗来维持足够的呼吸。然而,长时间的氧疗容易导致 BPD,目前尚无有效的治疗方法。因此,在住院期间预防早产儿 BPD 非常重要。研究表明,俯卧位可以有效地改善早产儿的氧合。然而,一些研究报告了俯卧位是否可以改善肺功能并降低 BPD 的发生率。本试验旨在确定与仰卧位相比,俯卧位是否可以降低早产儿 BPD 的发生率并改善肺功能。

方法和分析

这是一项单中心、单盲、随机对照试验,研究俯卧位对早产儿的影响。在每日喂养后,早产儿将先侧卧 30 分钟;然后上午和下午各在仰卧位(对照组)或俯卧位(干预组)各 2 小时。此外,两组婴儿根据医疗需要,在其余时间内交替仰卧位或侧卧位。研究从早产儿入院后 5 天内稳定开始,至出院或胎龄 36 周结束。主要结局是无 BPD 的生存率。次要结局包括肺功能参数和肺氧饱和度。

伦理和传播

本试验已获得西南医科大学附属医院伦理委员会的批准(批准文号 KY2021186)。结果将发表在同行评议的期刊上。

试验注册号

ChiCTR2100049847。

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