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NASCITA 意大利出生队列研究:研究方案。

NASCITA Italian birth cohort study: a study protocol.

机构信息

Laboratory for Mother and Child Health, Department of Public Health, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.

President Associazione Culturale Pediatri (ACP), Narbolia, Italy.

出版信息

BMC Pediatr. 2020 Feb 19;20(1):80. doi: 10.1186/s12887-020-1961-1.

DOI:10.1186/s12887-020-1961-1
PMID:32075601
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7029570/
Abstract

BACKGROUND

Young children's healthy development depends on nurturing care, which ensures health, nutrition, responsive caregiving, safety and security, and early learning. Infancy and childhood are characterized by rapid growth and development, and these two factors contribute largely to determining health status and well-being across the lifespan. Identification of modifiable risk factors and prognostic factors during the critical periods of life will contribute to the development of effective prevention and intervention strategies. The NASCITA (NAscere e creSCere in ITAlia) study was created to evaluate physical, cognitive, and psychological development, health status and health resource utilization during the first six years of life in a cohort of newborns, and to evaluate potential associated factors.

METHODS

NASCITA is an ongoing, dynamic, prospective, population-based birth cohort study of an expected number of more than 5000 newborns who will be recruited in 22 national geographic clusters starting in 2019. It was designed to follow children from birth to school entry age for a wide range of determinants, disorders, and diseases. Recruitment of the newborns (and their parents) will take place during the first routine well-child visit, which takes place at the office of the pediatrician assigned to them by the local health unit of residence, and which is scheduled for all newborns born in Italy within the first 45 days of their life. Data will be web-based and collected by the family pediatricians during each of the 7 standard well-child visits scheduled for all children during their first 6 years of life. Information on every contact with the enrolled children in addition to these prescheduled visits will be also recorded.

DISCUSSION

The NASCITA cohort study provides a framework in which children are followed from birth to six-years of age. NASCITA will broaden our understanding of the contribution of early-life factors to infant and child health and development. NASCITA provides opportunities to initiate new studies, also experimental ones, in parts of the cohort, and will contribute relevant information on determinants and health outcomes to policy and decision makers. Cohort details can be found on https://coortenascita.marionegri.it.

TRIAL REGISTRATION

Clinicaltrials.gov: NCT03894566. Ethics committee approval: 6 February 2019, Verbale N 59.

摘要

背景

儿童的健康发展依赖于养育关怀,这可确保其健康、营养、得到回应的照护、安全有保障和早期学习。婴儿期和儿童期的特点是快速生长和发育,这两个因素在很大程度上决定了整个生命周期的健康状况和幸福感。在生命的关键时期确定可改变的风险因素和预后因素,将有助于制定有效的预防和干预策略。NASCITA(意大利出生与成长研究)旨在评估 5000 多名新生儿队列在生命的头六年中的身体、认知和心理发育、健康状况和健康资源利用情况,并评估潜在的相关因素。

方法

NASCITA 是一项正在进行的、动态的、前瞻性的、基于人群的出生队列研究,预计将招募 22 个国家地理集群中的 5000 多名新生儿。该研究旨在从出生到入学年龄跟踪儿童,涵盖广泛的决定因素、疾病和病症。新生儿(及其父母)的招募将在他们的家庭儿科医生办公室进行,这些医生是由他们居住的当地卫生单位分配的,预计将在意大利出生的所有新生儿生命的头 45 天内进行。数据将通过网络进行收集,由家庭儿科医生在为所有儿童安排的 7 次标准健康检查中进行。除了这些预定的访问之外,还将记录与入组儿童的每次接触信息。

讨论

NASCITA 队列研究为从出生到 6 岁的儿童提供了一个跟踪框架。NASCITA 将拓宽我们对早期生活因素对婴儿和儿童健康和发育的贡献的理解。NASCITA 为在队列的某些部分开展新的研究,包括实验研究提供了机会,并将为政策制定者和决策者提供有关决定因素和健康结果的相关信息。队列详情可在 https://coortenascita.marionegri.it 上找到。

试验注册

Clinicaltrials.gov:NCT03894566。伦理委员会批准:2019 年 2 月 6 日,Verbale N 59。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2c43/7029570/2f715abe61d0/12887_2020_1961_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2c43/7029570/144590cf0368/12887_2020_1961_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2c43/7029570/2f715abe61d0/12887_2020_1961_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2c43/7029570/144590cf0368/12887_2020_1961_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2c43/7029570/2f715abe61d0/12887_2020_1961_Fig2_HTML.jpg

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