Follow-up of Children With Gastrointestinal Malformations and Postnatal Surgery

Study Overview
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Brief Summary
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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 Description
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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).

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

Conditions
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Digestive System Abnormalities

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gastrointestinal malformations<br>Children who underwent standardized neonatal pediatric surgery due to gastrointestinal malformations | |
| No gastrointestinal malformations<br>Control group of healthy children matched concerning gestational age, weight class and gender | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of Bayley Scales of Infant Development II Assessment | Score consisting of cognitive, verbal, nonverbal and motor development levels | 18 Months to 36 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometric and psychological changes | Growth of patients compared to a healthy control group Post-traumatic stress situations in families Psycho-emotional competence of the children | 18 Months to 36 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congenital abnormalities, Digestive system abnormalities, Neonatal surgery, Neonatal anesthesia, Bayley Scales of Infant Development II