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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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).
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Hessen
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Frankfurt/M, Hessen, Alemania, 60590
- Johann Wolfgang Goethe University Hospital, Department of Neonatology
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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).
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Score of Bayley Scales of Infant Development II Assessment
Periodo de tiempo: 18 Months to 36 Months
|
Score consisting of cognitive, verbal, nonverbal and motor development levels
|
18 Months to 36 Months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Anthropometric and psychological changes
Periodo de tiempo: 18 Months to 36 Months
|
|
18 Months to 36 Months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Antje Allendorf-Hofstetter, MD, Johann Wolfgang Goethe University Hospital Frankfurt/M, Department of Neonatology
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 01072011FraMal
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