Follow-up of Children With Gastrointestinal Malformations and Postnatal Surgery
NCT ID: NCT01451307
Last Updated: 2013-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
80 participants
OBSERVATIONAL
2011-09-30
2013-08-31
Brief Summary
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To measure the neurodevelopment, the children will be tested with the Bayley Scales of Infant Development II Assessment.
Detailed Description
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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).
Conditions
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Keywords
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Gastrointestinal malformations
Children who underwent standardized neonatal pediatric surgery due to gastrointestinal malformations
No interventions assigned to this group
No gastrointestinal malformations
Control group of healthy children matched concerning gestational age, weight class and gender
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
18 Months
36 Months
ALL
Yes
Sponsors
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Goethe University
OTHER
Responsible Party
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Antje Allendorf-Hofstetter
Principal Investigator
Principal Investigators
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Antje Allendorf-Hofstetter, MD
Role: PRINCIPAL_INVESTIGATOR
Johann Wolfgang Goethe University Hospital Frankfurt/M, Department of Neonatology
Locations
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Johann Wolfgang Goethe University Hospital, Department of Neonatology
Frankfurt/M, Hesse, Germany
Countries
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References
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Walker K, Halliday R, Holland AJ, Karskens C, Badawi N. Early developmental outcome of infants with infantile hypertrophic pyloric stenosis. J Pediatr Surg. 2010 Dec;45(12):2369-72. doi: 10.1016/j.jpedsurg.2010.08.035.
Other Identifiers
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01072011FraMal
Identifier Type: -
Identifier Source: org_study_id