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

Digestive System Abnormalities Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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). ;

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Congenital Abnormalities
• Digestive System Abnormalities

• NCT number: NCT01451307
• Study type: Observational
• Source: Goethe University
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Completion date: August 2013