此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Stanford's Outcomes Research in Kids (STORK)

2021年3月16日 更新者:Julie Parsonnet、Stanford University

Stanford's Outcomes Research in Kids (STORK)

The investigators intend to investigate whether the rise in childhood obesity is caused by the loss of recurrent and chronic infections in modern, industrialized society, beginning in utero and extending through early childhood. The investigators will also examine whether the antimicrobial triclosan, present in numerous cleaning and hygiene products, decreases the incidence of infection within a household.

研究概览

研究类型

观察性的

注册 (实际的)

361

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • California
      • Stanford、California、美国、94305
        • Stanford University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

女性

取样方法

非概率样本

研究人群

The study population will be enrolled from the population of pregnant women attending obstetric clinics for the first antenatal visit. Each woman will be followed throughout her pregnancy and then she and her baby will be followed over the first three years of the baby's life (and more if possible).

描述

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to participate in the study:

  1. Able to provide written informed consent.
  2. Able to communicate effectively in verbal English or Spanish.
  3. Willing to provide blood, saliva, urine and stool specimens from herself, and willing to provide blood, saliva, urine and stool specimens from her infant.
  4. Willing to provide consent for review of Primary Provider Medical Records regarding, for the mother, medical history and infectious and other conditions during pregnancy, and for the infant, Apgar scores, height and weight measurements at birth and over time, infectious and other disease diagnoses and treatment, and vaccination records.

Exclusion Criteria:

  1. More than one fetus.
  2. High risk pregnancy.
  3. Intent to move from the Bay Area within three years after enrollment.
  4. History of diagnosis and/or treatment, and any current diagnosis or treatment, of type 1 diabetes or of major mental illness.
  5. History of diagnosis and/or treatment, and any current diagnosis or treatment, of a thyroid disorder or other endocrine condition.
  6. History of diagnosis and/or treatment, and any current diagnosis or treatment that has resulted in severe immunosuppression.
  7. A household member who has a compromised immune system
  8. Other conditions that in the opinion of the PI would make the subject an unacceptable candidate for this study.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
No triclosan / Triclosan
Participants are randomized to receive household and personal cleaning products from one of 2 arms: products that either do not contain triclosan or that may contain triclosan. Participants select products from an arm-specific list of commercially available items.
An intervention is nested within the observational cohort study as a secondary outcome. Commercially available household and personal cleaning products that either do not contain triclosan or that may contain triclosan will be delivered to the household every 4 months for the duration of the study. All cleaning products will be formulated, packaged and labeled by the original manufacturer with no modification for this study. Use of these products will be as per each individual product's label and at the discretion of the participant.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Height-for-weight Z scores
大体时间:Age 3 years
We will determine whether an association exists between height-for-weight Z-score (with adjustment for age and sex) and infectious disease load.
Age 3 years

次要结果测量

结果测量
大体时间
Cumulative sick-days
大体时间:In utero to 3 years of age
In utero to 3 years of age

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Catherine Ley, PhD、Senior Research Scientist

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2011年11月17日

初级完成 (实际的)

2019年12月1日

研究完成 (实际的)

2019年12月1日

研究注册日期

首次提交

2011年9月1日

首先提交符合 QC 标准的

2011年9月26日

首次发布 (估计)

2011年9月28日

研究记录更新

最后更新发布 (实际的)

2021年3月17日

上次提交的符合 QC 标准的更新

2021年3月16日

最后验证

2021年3月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅