- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01451307
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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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).
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
Hessen
-
Frankfurt/M, Hessen, Allemagne, 60590
- Johann Wolfgang Goethe University Hospital, Department of Neonatology
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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).
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
---|
Gastrointestinal malformations
Children who underwent standardized neonatal pediatric surgery due to gastrointestinal malformations
|
No gastrointestinal malformations
Control group of healthy children matched concerning gestational age, weight class and gender
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Score of Bayley Scales of Infant Development II Assessment
Délai: 18 Months to 36 Months
|
Score consisting of cognitive, verbal, nonverbal and motor development levels
|
18 Months to 36 Months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Anthropometric and psychological changes
Délai: 18 Months to 36 Months
|
|
18 Months to 36 Months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Antje Allendorf-Hofstetter, MD, Johann Wolfgang Goethe University Hospital Frankfurt/M, Department of Neonatology
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 01072011FraMal
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