Follow-up of Children With Gastrointestinal Malformations and Postnatal Surgery (FraMal)

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

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.

Study Overview

• Status: Completed
• Conditions: Digestive System Abnormalities

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 Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Frankfurt/M, Hessen, Germany, 60590
      • Johann Wolfgang Goethe University Hospital, Department of Neonatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Gastrointestinal malformations; Children who underwent standardized neonatal pediatric surgery due to gastrointestinal malformations
No gastrointestinal malformations; Control group of healthy children matched concerning gestational age, weight class and gender

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score of Bayley Scales of Infant Development II Assessment	Score consisting of cognitive, verbal, nonverbal and motor development levels	18 Months to 36 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Goethe University
• Investigators: Principal Investigator: Antje Allendorf-Hofstetter, MD, Johann Wolfgang Goethe University Hospital Frankfurt/M, Department of Neonatology

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: August 4, 2011
• First Submitted That Met QC Criteria: October 11, 2011
• First Posted (Estimate): October 13, 2011

Study Record Updates

• Last Update Posted (Estimate): September 5, 2013
• Last Update Submitted That Met QC Criteria: September 4, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Neonatal surgery; Congenital abnormalities; Digestive system abnormalities; Neonatal anesthesia; Bayley Scales of Infant Development II
• Additional Relevant MeSH Terms: Digestive System Diseases; Congenital Abnormalities; Digestive System Abnormalities
• Other Study ID Numbers: 01072011FraMal