Text Size

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

This study is currently recruiting participants.
Verified October 2011 by Goethe University
Sponsor:
Information provided by (Responsible Party):
Antje Allendorf-Hofstetter, Goethe University
ClinicalTrials.gov Identifier:
NCT01451307
First received: August 4, 2011
Last updated: October 11, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition
Digestive System Abnormalities

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Follow-up Study of Children Aged 2 Years With Gastrointestinal Malformations and Postnatal Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Goethe University:

Primary Outcome Measures:
  • Score of Bayley Scales of Infant Development II Assessment [ Time Frame: 18 Months to 36 Months ] [ Designated as safety issue: No ]
    Score consisting of cognitive, verbal, nonverbal and motor development levels


Secondary Outcome Measures:
  • Anthropometric and psychological changes [ Time Frame: 18 Months to 36 Months ] [ Designated as safety issue: No ]
    • Growth of patients compared to a healthy control group
    • Post-traumatic stress situations in families
    • Psycho-emotional competence of the children


Estimated Enrollment: 80
Study Start Date: September 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Ages Eligible for Study:   18 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01451307

Contacts
Contact: Antje Allendorf-Hofstetter, MD +49696301 ext 5809 antje.allendorf@kgu.de
Contact: Rolf L. Schlößer, MD +49696301 ext 5120 rolf.schloesser@kgu.de

Locations
Germany
Johann Wolfgang Goethe University Hospital, Department of Neonatology Recruiting
Frankfurt/M, Hessen, Germany, 60590
Principal Investigator: Antje Allendorf-Hofstetter, MD            
Sponsors and Collaborators
Goethe University
Investigators
Principal Investigator: Antje Allendorf-Hofstetter, MD Johann Wolfgang Goethe University Hospital Frankfurt/M, Department of Neonatology
  More Information

Publications:

Responsible Party: Antje Allendorf-Hofstetter, Principal Investigator, Goethe University
ClinicalTrials.gov Identifier: NCT01451307     History of Changes
Other Study ID Numbers: 01072011FraMal
Study First Received: August 4, 2011
Last Updated: October 11, 2011
Health Authority: Germany: Ethics Commission of the university of Frankfurt/M

Keywords provided by Goethe University:
Congenital abnormalities
Digestive system abnormalities
Neonatal surgery
Neonatal anesthesia
Bayley Scales of Infant Development II

Additional relevant MeSH terms:
Duodenal Diseases
Congenital Abnormalities
Hirschsprung Disease
Duodenal Obstruction
Hernia, Umbilical
Digestive System Abnormalities
Digestive System Diseases
Megacolon
Colonic Diseases
 Intestinal Diseases
Gastrointestinal Diseases
Intestinal Obstruction
Infant, Newborn, Diseases
Hernia, Ventral
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 19, 2013