Follow-up of Children With Gastrointestinal Malformations and Postnatal Surgery

Goethe University80 enrolled

Overview

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.

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Digestive System Abnormalities

Eligibility

Sex: ALLMin age: 18 MonthsMax age: 36 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Johann Wolfgang Goethe University Hospital, Department of Neonatology

Frankfurt/M, Hesse, Germany

Outcomes

Primary Outcomes

Score of Bayley Scales of Infant Development II Assessment

Score consisting of cognitive, verbal, nonverbal and motor development levels

Time frame: 18 Months to 36 Months

Secondary Outcomes

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

Time frame: 18 Months to 36 Months

Data from ClinicalTrials.gov

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