Follow-up of Children With Gastrointestinal Malformations and Postnatal Surgery

Digestive System Abnormalities Clinical Trial

— FraMal  

Official title:

Follow-up Study of Children Aged 2 Years With Gastrointestinal Malformations and Postnatal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01451307
• Other study ID #: 01072011FraMal
• Status: Completed
• Phase: N/A
• First received: August 4, 2011
• Last updated: September 4, 2013
• Start date: September 2011
• Est. completion date: August 2013

Study information

• Verified date: September 2013
• Source: Goethe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission of the university of Frankfurt/M
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Months to 36 Months

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Congenital Abnormalities
• Digestive System Abnormalities

Locations

Country	Name	City	State
Germany	Johann Wolfgang Goethe University Hospital, Department of Neonatology	Frankfurt/M	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Goethe University

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Walker K, Halliday R, Holland AJ, Karskens C, Badawi N. Early developmental outcome of infants with infantile hypertrophic pyloric stenosis. J Pediatr Surg. 2010 Dec;45(12):2369-72. doi: 10.1016/j.jpedsurg.2010.08.035. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score of Bayley Scales of Infant Development II Assessment	Score consisting of cognitive, verbal, nonverbal and motor development levels	18 Months to 36 Months	No
Secondary	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	18 Months to 36 Months	No