Follow-up of Children With Gastrointestinal Malformations and Postnatal Surgery (FraMal)
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
条件
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
注册 (实际的)
联系人和位置
学习地点
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Hessen
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Frankfurt/M、Hessen、德国、60590
- Johann Wolfgang Goethe University Hospital, Department of Neonatology
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
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
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
|---|
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Gastrointestinal malformations
Children who underwent standardized neonatal pediatric surgery due to gastrointestinal malformations
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No gastrointestinal malformations
Control group of healthy children matched concerning gestational age, weight class and gender
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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
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Score consisting of cognitive, verbal, nonverbal and motor development levels
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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
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18 Months to 36 Months
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合作者和调查者
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
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 01072011FraMal
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