Follow-up of Children With Gastrointestinal Malformations and Postnatal Surgery

Completed

• Conditions: Digestive System Abnormalities

• Registration Number: NCT01451307
• Lead Sponsor: Goethe University

Brief Summary

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

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 Timeline

• Study First Submitted: 2011-08-04
• Study Start: 2011-09
• Study First Submitted QC: 2011-10-11
• Study First Posted: 2011-10-13
• Primary Completion: 2013-07
• Study Completion: 2013-08
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-04
• Last Update Posted: 2013-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Score of Bayley Scales of Infant Development II Assessment	18 Months to 36 Months	Score consisting of cognitive, verbal, nonverbal and motor development levels

Secondary Outcome Measures

Name	Time	Method
Anthropometric and psychological changes	18 Months to 36 Months	* Growth of patients compared to a healthy control group; * Post-traumatic stress situations in families; * Psycho-emotional competence of the children

Trial Locations

Locations (1)

Johann Wolfgang Goethe University Hospital, Department of Neonatology; 🇩🇪 Frankfurt/M, Hessen, Germany