Johann Wolfgang Goethe University Hospital, Department of Neonatology
Frankfurt/M, Hesse, 60590, Germany
NCT Number: NCT01451307
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.
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Notify Me18 month–36 month
All sexes
Observational
Frankfurt/M, Hesse, 60590, Germany
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:
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients:
Healthy individuals:
Exclusion criteria
(both groups):
Time frame: 18 Months to 36 Months
Score consisting of cognitive, verbal, nonverbal and motor development levels
Time frame: 18 Months to 36 Months
Goethe University
Other
Follow-up Study of Children Aged 2 Years With Gastrointestinal Malformations and Postnatal Surgery
Acronym: FraMal
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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