Clinical trial NCT01451307: Follow-up of Children With Gastrointestinal Malformations and Postnatal Surgery
Official title: Follow-up Study of Children Aged 2 Years With Gastrointestinal Malformations and Postnatal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Digestive System Abnormalities
Keywords: Congenital abnormalities
Digestive system abnormalities
Neonatal surgery
Neonatal anesthesia
Bayley Scales of Infant Development II
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2011-10-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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).

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).

Eligibility criteria: 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

Primary outcomes:
measure: Score of Bayley Scales of Infant Development II Assessment
timeFrame: 18 Months to 36 Months
Secondary outcomes:
measure: Anthropometric and psychological changes
timeFrame: 18 Months to 36 Months
Other outcomes:
Locations:
city: Frankfurt/M
country: Germany
facility: Johann Wolfgang Goethe University Hospital, Department of Neonatology
state: Hessen
Study officials:
affiliation: Johann Wolfgang Goethe University Hospital Frankfurt/M, Department of Neonatology
name: Antje Allendorf-Hofstetter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.