Follow-up of Children With Gastrointestinal Malformations and Postnatal Surgery (FraMal)
|ClinicalTrials.gov Identifier: NCT01451307|
Recruitment Status : Completed
First Posted : October 13, 2011
Last Update Posted : September 5, 2013
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.
|Condition or disease|
|Digestive System Abnormalities|
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.
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.
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).
|Study Type :||Observational|
|Actual Enrollment :||80 participants|
|Observational Model:||Case Control|
|Official Title:||Follow-up Study of Children Aged 2 Years With Gastrointestinal Malformations and Postnatal Surgery|
|Study Start Date :||September 2011|
|Primary Completion Date :||July 2013|
|Study Completion Date :||August 2013|
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
- Score of Bayley Scales of Infant Development II Assessment [ Time Frame: 18 Months to 36 Months ]Score consisting of cognitive, verbal, nonverbal and motor development levels
- Anthropometric and psychological changes [ Time Frame: 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01451307
|Johann Wolfgang Goethe University Hospital, Department of Neonatology|
|Frankfurt/M, Hessen, Germany, 60590|
|Principal Investigator:||Antje Allendorf-Hofstetter, MD||Johann Wolfgang Goethe University Hospital Frankfurt/M, Department of Neonatology|