Follow-up Study of Children Aged 2 Years With Gastrointestinal Malformations and Postnatal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Score of Bayley Scales of Infant Development II Assessment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
- •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
- •week of gestation at birth
- •Follow-up appointment when not acutely ill
- •Parental consent
- •Exclusion Criteria (both groups):
- •Absence of parental consent
排除标准
- 未提供
结局指标
主要结局
Score of Bayley Scales of Infant Development II Assessment
时间窗: 18 Months to 36 Months
Score consisting of cognitive, verbal, nonverbal and motor development levels
次要结局
- Anthropometric and psychological changes(18 Months to 36 Months)
研究者
Antje Allendorf-Hofstetter
Principal Investigator
Goethe University