Status:
COMPLETED
Follow-up of Children With Gastrointestinal Malformations and Postnatal Surgery
Lead Sponsor:
Goethe University
Conditions:
Digestive System Abnormalities
Eligibility:
All Genders
18-36 years
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 ps...
Detailed 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 developm...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01451307
Start Date
September 1 2011
End Date
August 1 2013
Last Update
September 5 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Johann Wolfgang Goethe University Hospital, Department of Neonatology
Frankfurt/M, Hesse, Germany, 60590