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Follow-up of Children With Gastrointestinal Malformations and Postnatal Surgery (FraMal)

2013年9月4日 更新者:Antje Allendorf-Hofstetter、Goethe University

Follow-up Study of Children Aged 2 Years With Gastrointestinal Malformations and Postnatal Surgery

The aim of this single center study is to measure the impact of standardized neonatal pediatric surgeries due to gastrointestinal malformations on the children's motor and cognitive development and psycho-emotional competence.

To measure the neurodevelopment, the children will be tested with the Bayley Scales of Infant Development II Assessment.

研究概览

地位

完全的

详细说明

Objectives:

The primary objective of this study is to compare differences in the score of Bayley Scales of Infant Development II Assessment (consisting of cognitive, verbal, nonverbal, motor development levels) between children with gastrointestinal malformations and early postnatal surgery at the age of 2 years and a control group.

The secondary objective is to measure the growth of the patients compared to healthy children in the control group, to capture post-traumatic stress situations in families, and to capture the children's psycho-emotional competence.

Study design:

The study is designed as a cross-sectional single center study. The study patients are children of 2 years of age who underwent neonatal surgery in our clinic since June 2008 due to a gastrointestinal malformation.

The control group consists of matched pairs concerning gestational age, weight and gender.

The study consists of five parts:

  • Introductory interview including the medical history
  • Bayley Scales of Infant Development II Assessment
  • Pediatric examination with anthropometry
  • Questionnaire survey of post-traumatic stress situation
  • Final conversation with the parents about the results

The neurodevelopmental testing is performed by the child psychologist and the pediatric examination by the pediatrician.

Study population:

The study is purely exploratory and based on the number of patients born in our hospital with the malformations mentioned above (approximately 40).

Each patient is compared against a healthy child of the same gestational age, weight class and gender (control group).

研究类型

观察性的

注册 (实际的)

80

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

    • Hessen
      • Frankfurt/M、Hessen、德国、60590
        • Johann Wolfgang Goethe University Hospital, Department of Neonatology

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

1年 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

The study is purely exploratory and based on the number of patients born in our hospital with the malformations mentioned above (approximately 40).

Each patient is compared against a healthy child of the same gestational age, weight class and gender (control group).

描述

Inclusion Criteria:

Patients:

  • At follow-up between 18 and 36 months of age
  • At birth a gastrointestinal malformation
  • Postnatal surgery
  • No other serious malformations
  • No serious complications of birth (e.g. asphyxia)
  • > = 33. week of gestation at birth
  • Follow-up appointment when not acutely ill
  • Parental Consent

Healthy individuals:

  • At follow-up between 18 and 36 months of age
  • Uncomplicated postnatal period
  • No malformations
  • No surgery until follow-up appointment
  • > = 33. week of gestation at birth
  • Follow-up appointment when not acutely ill
  • Parental consent

Exclusion Criteria (both groups):

  • Absence of parental consent

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
Gastrointestinal malformations
Children who underwent standardized neonatal pediatric surgery due to gastrointestinal malformations
No gastrointestinal malformations
Control group of healthy children matched concerning gestational age, weight class and gender

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
Score of Bayley Scales of Infant Development II Assessment
大体时间:18 Months to 36 Months
Score consisting of cognitive, verbal, nonverbal and motor development levels
18 Months to 36 Months

次要结果测量

结果测量
措施说明
大体时间
Anthropometric and psychological changes
大体时间:18 Months to 36 Months
  • Growth of patients compared to a healthy control group
  • Post-traumatic stress situations in families
  • Psycho-emotional competence of the children
18 Months to 36 Months

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:Antje Allendorf-Hofstetter, MD、Johann Wolfgang Goethe University Hospital Frankfurt/M, Department of Neonatology

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

2011年9月1日

初级完成 (实际的)

2013年7月1日

研究完成 (实际的)

2013年8月1日

研究注册日期

首次提交

2011年8月4日

首先提交符合 QC 标准的

2011年10月11日

首次发布 (估计)

2011年10月13日

研究记录更新

最后更新发布 (估计)

2013年9月5日

上次提交的符合 QC 标准的更新

2013年9月4日

最后验证

2013年9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.

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