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Completed

NCT Number: NCT01451307

Follow-up of Children 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.

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Key information

Age range

18 month–36 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Johann Wolfgang Goethe University Hospital, Department of Neonatology

Frankfurt/M, Hesse, 60590, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Score of Bayley Scales of Infant Development II Assessment

    Time frame: 18 Months to 36 Months

    Score consisting of cognitive, verbal, nonverbal and motor development levels

Secondary outcomes

  1. Anthropometric and psychological changes

    Time frame: 18 Months to 36 Months

    • Growth of patients compared to a healthy control group
    • Post-traumatic stress situations in families
    • Psycho-emotional competence of the children

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Registry information

Official study title

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

Acronym: FraMal

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 13, 2011
Registry last updated
Sep 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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