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队列研究方案:广州高危婴儿队列研究。

Cohort protocol: Guangzhou High-Risk Infant Cohort study.

作者信息

Hu Pian, Han Azhu, Hu Yan, Wen Yuqi, Liang Jingjing, Xiao Wanqi, Lin Suifang, Song Yanyan, Tan Xuying, Zhao Xiaopeng, Dong Haipeng, Liu Qianyun, Zhang Huayan, Tao Li, Yuan Yuan

机构信息

Department of Child Health Care, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.

Department of Child Health Care, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China

出版信息

BMJ Open. 2020 Oct 16;10(10):e037829. doi: 10.1136/bmjopen-2020-037829.

Abstract

INTRODUCTION

Despite the increase in the survival rate of high-risk infants (HRIs) worldwide, the prevalence of motor and neurodevelopmental sequelae in such newborns has not shown concomitant improvement. Meanwhile, there are few cohorts that explore factors related to the development of HRIs in China. Therefore, the Guangzhou High-Risk Infant Cohort (GHRIC) has been designed to examine the complex relationships among a myriad of factors influencing growth and development in such children.

METHODS AND ANALYSIS

The GHRIC study is a prospective cohort study that by the year 2023 will enrol an estimated total of 3000 HRIs from Guangzhou Women and Children's Medical Center (GWCMC) in Guangzhou, China. This study is designed to assess the growth and cognitive characteristics of HRIs and the risk factors affecting their development and prognoses. Data on risk factors, neurodevelopmental and cognitive-function evaluations, laboratory results, and specimens will be collected and analysed. Information on perinatal and clinical interventions for these infants will also be recorded during regular follow-up visits until age 6.

ETHICS AND DISSEMINATION

The protocol for this study has been approved by the Research Ethics Committee of GWCMC, which accepted responsibility for supervising all of the aspects of the study (No. 2017102712). Study outcomes will be disseminated through conference presentations, peer-reviewed publications, the Internet and social media.

TRIAL REGISTRATION NUMBER

ChiCTR-EOC-17013236.

摘要

引言

尽管全球高危婴儿(HRI)的存活率有所提高,但此类新生儿运动和神经发育后遗症的患病率并未随之改善。与此同时,在中国,很少有队列研究探讨与高危婴儿发育相关的因素。因此,广州高危婴儿队列研究(GHRIC)旨在研究影响此类儿童生长发育的众多因素之间的复杂关系。

方法与分析

GHRIC研究是一项前瞻性队列研究,到2023年预计将从中国广州妇女儿童医疗中心(GWCMC)招募总计3000名高危婴儿。本研究旨在评估高危婴儿的生长和认知特征以及影响其发育和预后的危险因素。将收集并分析有关危险因素、神经发育和认知功能评估、实验室检查结果及样本的数据。在定期随访至6岁期间,还将记录这些婴儿围产期和临床干预的信息。

伦理与传播

本研究方案已获得GWCMC研究伦理委员会批准,该委员会负责监督研究的所有方面(编号:2017102712)。研究结果将通过会议报告、同行评审出版物、互联网和社交媒体进行传播。

试验注册号

ChiCTR-EOC-17013236。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eee8/7569926/1188687c240b/bmjopen-2020-037829f01.jpg

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