Clinical Trial: Follow-up of Children With Gastrointestinal Malformations and Postnatal Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief 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.


Detailed Summary:

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:

Sponsor: Goethe University

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome: 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


Original Secondary Outcome: Same as current

Information By: Goethe University

Dates:
Date Received: August 4, 2011
Date Started: September 2011
Date Completion:
Last Updated: September 4, 2013
Last Verified: September 2013