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中国极早产儿不良预后(CARE-早产)队列研究:一项前瞻性多中心队列研究的研究设计和基线特征

The Chinese adverse prognosis of very preterm infants (CARE-Preterm) cohort: study design and baseline characteristics for a prospective multicenter cohort study.

作者信息

Shi Ranran, Dong Xiaoyu, Wang Li, Zhang Wenwen, Reddy Simmy, Yu Yonghui

机构信息

Department of Neonatology, Shandong Provincial Hospital affiliated to Shandong First Medical University, No. 324, Jingwu Road, HuaiYin District, Jinan, 250021, Shandong, China.

Department of Neonatology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.

出版信息

BMC Pediatr. 2025 May 13;25(1):377. doi: 10.1186/s12887-025-05722-5.

Abstract

BACKGROUND

As the increasing survival of preterm infants bearing lower gestational age (GA) and birth weight (BW), new challenges have emerged regarding their management and prognosis. In low- and middle-income countries, there is notable absence of prospective multicenter cohorts to accurately reflect their real treatment capacity for these preterm infants. This cohort study aims to fill this gap by investigating the impact of perinatal management on the prognosis of preterm infants in Northern China.

METHODS

The Chinese Adverse Prognosis of Very Preterm infants (CARE-Preterm) cohort study is a prospective, multicenter, longitudinal, and open cohort study based on the Sino-northern Neonatal Network (SNN) since 2018, covering 60 neonatal intensive care units from 8 densely-populated provinces and autonomous regions in Northern China. All very preterm infants (VPIs) born with GA < 32 weeks or very low birth weight infants (VLBWI) born with BW < 1500 g admitted alive to the participating units are continuously enrolled from January 1, 2018. Baseline clinical data and biological samples are longitudinally collected from the perinatal period to discharge.

RESULTS

From January 1, 2018, to December 31, 2022, approximately 10,447 infants were included and 9325 infants were discharged alive. Notably,1472 (14.09%) were born with GA < 28 weeks, and 1566 (14.99%) with BW < 1000 g. Among the 9325 survivors, the smallest GA and BW were 23 weeks and 450 g, respectively. The main findings of this cohort study highlight substantial improvements in perinatal medicine treatment capabilities and current treatment bottlenecks.

CONCLUSION

This cohort study provides crucial insight into updated real-world data from low- and middle-income countries, helping to identify treatment bottlenecks and improve both the survival rate and life quality for preterm infants. Furthermore, it is expected to serve as a reference for establishing population-based cohort studies in other low and middle-income countries.

TRIAL REGISTRATION

The current projects based on this cohort study have been registered in the Chinese Clinical Trial Registration Center (Registration number: ChiCTR1900025234, ChiCTR1900020861, ChiCTR2000037918, ChiCTR2000029162, ChiCTR2100053780 and ChiCTR2200066764).

摘要

背景

随着孕周(GA)和出生体重(BW)较低的早产儿存活率不断提高,其管理和预后出现了新的挑战。在低收入和中等收入国家,明显缺乏前瞻性多中心队列研究来准确反映其对这些早产儿的实际治疗能力。本队列研究旨在通过调查围产期管理对中国北方早产儿预后的影响来填补这一空白。

方法

中国极早早产儿不良预后(CARE - Preterm)队列研究是一项自2018年以来基于中国北方新生儿网络(SNN)的前瞻性、多中心、纵向和开放性队列研究,覆盖中国北方8个人口密集省份和自治区的60个新生儿重症监护病房。自2018年1月1日起,连续纳入所有孕周<32周的极早早产儿(VPI)或出生体重<1500g的极低出生体重儿(VLBWI),且这些婴儿存活入院至参与单位。从围产期到出院纵向收集基线临床数据和生物样本。

结果

从2018年1月1日至2022年12月31日,共纳入约10447例婴儿,9325例婴儿存活出院。值得注意的是,1472例(14.09%)婴儿出生时孕周<28周,1566例(14.99%)婴儿出生体重<1000g。在9325例存活者中,最小孕周和出生体重分别为23周和450g。本队列研究的主要发现突出了围产医学治疗能力的显著提高以及当前的治疗瓶颈。

结论

本队列研究为低收入和中等收入国家的最新真实世界数据提供了关键见解,有助于识别治疗瓶颈,提高早产儿的存活率和生活质量。此外,有望为其他低收入和中等收入国家建立基于人群的队列研究提供参考。

试验注册

基于本队列研究的当前项目已在中国临床试验注册中心注册(注册号:ChiCTR1900025234、ChiCTR1900020861、ChiCTR2000037918、ChiCTR2000029162、ChiCTR2100053780和ChiCTR2200066764)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d042/12070726/ef1100d4a553/12887_2025_5722_Fig1_HTML.jpg

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