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Neurodevelopmental Outcomes of Preterm and Term Children

2016年1月13日 更新者:Icahn School of Medicine at Mount Sinai
This study will utilize two validated tools for assessing child development and behavior, to investigate the outcomes for children born preterm compared with those born at full term. Two hundred children born or cared for during the neonatal period at Mount Sinai Hospital will be enrolled. Parents will be asked to complete a behavioral assessment questionnaire, and which will assess development in an examination administered by a trained occupational therapist at Mount Sinai Hospital.

研究概览

地位

终止

条件

详细说明

This research will be completed at Mount Sinai Hospital. All participants will be identified from Mount Sinai Hospital records of infants born at MSH and/or cared for in the Mount Sinai NICU on or after January 1, 2011, at full term or preterm. The study team will contact the parents of eligible potential participants by telephone to explain the study and ask if the parent will consent to their child's participation. If the parent agrees, we will make an appointment for the child to come to Mount Sinai for the evaluation using the Bayley-III. The parents will be mailed the study consent form, a fact sheet with information about the study, and the CBCL to complete before they bring their child to their appointment. Mount Sinai records from the birth hospitalization will be reviewed for the birth history and medical comorbidities. Mount Sinai medical records of the mother's obstetric care will also be accessed to obtain medical history from the pregnancy. If a participating child has received outpatient care at Mount Sinai, the investigators will access their record in Epic to obtain scores from previous developmental assessments and records of medical comorbidities. If they have not attended the Mount Sinai clinic, but have received outpatient care elsewhere, the parents will be asked to provide contact information for their pediatrician, and for permission to obtain their child's records.

研究类型

观察性的

注册 (实际的)

1

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

    • New York
      • New York、New York、美国、10029
        • Icahn School of Medicine at Mount Sinai

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

6个月 至 3年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

200 children born on or after January 1, 2011 at Mount Sinai or admitted to the Mount Sinai Hospital for newborn care.

描述

Inclusion Criteria:

  • Born on or after January 1, 2011
  • Admitted to the Mount Sinai Hospital for newborn care

Exclusion Criteria:

  • Non-English speaking

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
Full Term
Children born at full term on or after Jan 1, 2011
PreTerm
Children born preterm on or after Jan 1, 2011

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
Child Behavior Checklist (CBCL)
大体时间:day 1
The CBCL, completed by a primary caregiver, is a standardized assessment of behavioral problems categorized into externalizing or internalizing behaviors.
day 1

次要结果测量

结果测量
措施说明
大体时间
Bayley Scales of Development III (BayleyIII)
大体时间:day 1
The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) is used to measure developmental and behavioral outcomes. The Bayley-III is a standardized assessment of cognitive, motor, and language development administered by a trained researcher. The Bayley-III also includes social and emotional development questionnaire that is completed by a primary caregiver.
day 1

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

  • 首席研究员:Annemarie Stroustrup, MD, MPH、Icahn School of Medicine at Mount Sinai

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

2015年1月1日

初级完成 (实际的)

2015年1月1日

研究完成 (实际的)

2015年1月1日

研究注册日期

首次提交

2014年12月3日

首先提交符合 QC 标准的

2014年12月3日

首次发布 (估计)

2014年12月5日

研究记录更新

最后更新发布 (估计)

2016年1月14日

上次提交的符合 QC 标准的更新

2016年1月13日

最后验证

2016年1月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • GCO 12-0332-0001

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.

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