Follow-up of Children With Gastrointestinal Malformations and Postnatal Surgery (FraMal)
Follow-up Study of Children Aged 2 Years With Gastrointestinal Malformations and Postnatal Surgery
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.
Visão geral do estudo
Status
Condições
Descrição detalhada
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).
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Hessen
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Frankfurt/M, Hessen, Alemanha, 60590
- Johann Wolfgang Goethe University Hospital, Department of Neonatology
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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).
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
|---|
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Gastrointestinal malformations
Children who underwent standardized neonatal pediatric surgery due to gastrointestinal malformations
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No gastrointestinal malformations
Control group of healthy children matched concerning gestational age, weight class and gender
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Score of Bayley Scales of Infant Development II Assessment
Prazo: 18 Months to 36 Months
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Score consisting of cognitive, verbal, nonverbal and motor development levels
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18 Months to 36 Months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Anthropometric and psychological changes
Prazo: 18 Months to 36 Months
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18 Months to 36 Months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Antje Allendorf-Hofstetter, MD, Johann Wolfgang Goethe University Hospital Frankfurt/M, Department of Neonatology
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 01072011FraMal
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