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深圳新生儿复苏在线注册研究:一项前瞻性、多中心、开放性、观察性队列研究方案。

Neonatal Resuscitation Online Registry in Shenzhen: protocol for a prospective, multicentre, open, observational cohort study.

机构信息

Neonatology, Shenzhen Luohu People's Hospital, Shenzhen, Guangdong, China.

Neonatal Intensive Care Unit, Longgang District Maternity & Child Healthcare Hospital of Shenzhen City, Shenzhen, Guangdong, China.

出版信息

BMJ Open. 2024 Jun 10;14(6):e081670. doi: 10.1136/bmjopen-2023-081670.

DOI:10.1136/bmjopen-2023-081670
PMID:38858150
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11168126/
Abstract

INTRODUCTION

Preterm birth complications and neonatal asphyxia are the leading causes of neonatal mortality worldwide. Surviving preterm and asphyxiated newborns can develop neurological sequelae; therefore, timely and appropriate neonatal resuscitation is important to decrease neonatal mortality and disability rates. There are very few systematic studies on neonatal resuscitation in China, and its prognosis remains unclear. We established an online registry for neonatal resuscitation in Shenzhen based on Utstein's model and designed a prospective, multicentre, open, observational cohort study to address many of the limitations of existing studies. The aim of this study is to explore the implementation and management, risk factors and outcomes of neonatal resuscitation in Shenzhen.

METHODS AND ANALYSIS

This prospective, multicentre, open, observational cohort study will be conducted between January 2024 and December 2026 and will include >1500 newborns resuscitated at birth by positive pressure ventilation at five hospitals in Shenzhen, located in the south-central coastal area of Guangdong province, China. Maternal and infant information, resuscitation information, hospitalisation information and follow-up information will be collected. Maternal and infant information, resuscitation information and hospitalisation information will be collected from the clinical records of the patients. Follow-up information will include the results of follow-up examinations and outcomes, which will be recorded using the WeChat applet 'Resuscitation Follow-up'. These data will be provided by the neonatal guardians through the applet on their mobile phones. This study will provide a more comprehensive understanding of the implementation and management, risk factors and outcomes of neonatal resuscitation in Shenzhen; the findings will ultimately contribute to the reduction of neonatal mortality and disability rates in Shenzhen.

ETHICS AND DISSEMINATION

Our protocol has been approved by the Medical Ethics Committee of Shenzhen Luohu People's Hospital (2023-LHQRMYY-KYLL-048). We will present the study results at academic conferences and peer-reviewed paediatrics journals.

TRIAL REGISTRATION NUMBER

ChiCTR2300077368.

摘要

简介

早产并发症和新生儿窒息是全球新生儿死亡的主要原因。存活的早产儿和窒息新生儿可能会出现神经后遗症;因此,及时、适当的新生儿复苏对于降低新生儿死亡率和残疾率非常重要。中国对新生儿复苏的系统研究很少,其预后仍不清楚。我们基于 Utstein 模型在深圳建立了新生儿复苏在线注册,并设计了一项前瞻性、多中心、开放、观察性队列研究,以解决现有研究中的许多局限性。本研究旨在探讨深圳新生儿复苏的实施和管理、危险因素和结局。

方法和分析

这项前瞻性、多中心、开放、观察性队列研究将于 2024 年 1 月至 2026 年 12 月进行,将包括在中国广东省中南部沿海地区深圳的五家医院出生时通过正压通气复苏的>1500 名新生儿。将收集产妇和婴儿信息、复苏信息、住院信息和随访信息。产妇和婴儿信息、复苏信息和住院信息将从患者的临床记录中收集。随访信息将包括随访检查结果和结局,这些将通过微信小程序“复苏随访”记录。这些数据将由新生儿监护人通过手机上的小程序提供。本研究将提供对深圳新生儿复苏实施和管理、危险因素和结局的更全面了解;研究结果最终将有助于降低深圳的新生儿死亡率和残疾率。

伦理和传播

我们的方案已获得深圳罗湖人民医院医学伦理委员会的批准(2023-LHQRMYY-KYLL-048)。我们将在学术会议和同行评议的儿科期刊上展示研究结果。

试验注册号

ChiCTR2300077368。

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