Follow-up of Children With Gastrointestinal Malformations and Postnatal Surgery

NCT01451307 | Completed DMC

• 1 other identifier: 01072011FraMal
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Digestive System Abnormalities

Keywords

Congenital abnormalities; Digestive system abnormalities; Neonatal surgery; Neonatal anesthesia; Bayley Scales of Infant Development II

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Anthropometric and psychological changes

  18 Months to 36 Months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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).

You may qualify if:

• 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

You may not qualify if:

• Absence of parental consent

Sponsors & Collaborators

• Goethe University: lead

Study Sites (1)

Johann Wolfgang Goethe University Hospital, Department of Neonatology

Frankfurt/M, Hesse, 60590, Germany

Location

Related 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.

  PMID: 21129547 BACKGROUND

MeSH Terms

Conditions

Digestive System Abnormalities; Congenital Abnormalities

Condition Hierarchy (Ancestors)

Digestive System Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Antje Allendorf-Hofstetter, MD

  Johann Wolfgang Goethe University Hospital Frankfurt/M, Department of Neonatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 4, 2011
• First Posted: October 13, 2011
• Study Start: September 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: August 1, 2013
• Last Updated: September 5, 2013

Record last verified: 2013-09

Locations

DE (1)