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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01451307 |
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Date of registration:
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04/08/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Follow-up of Children With Gastrointestinal Malformations and Postnatal Surgery
FraMal |
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Scientific title:
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Follow-up Study of Children Aged 2 Years With Gastrointestinal Malformations and Postnatal Surgery |
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Date of first enrolment:
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September 2011 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01451307 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Cross-Sectional
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Antje Allendorf-Hofstetter, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Johann Wolfgang Goethe University Hospital Frankfurt/M, Department of Neonatology |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Months
Age maximum:
36 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Digestive System Abnormalities
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Primary Outcome(s)
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Score of Bayley Scales of Infant Development II Assessment
[Time Frame: 18 Months to 36 Months]
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Secondary Outcome(s)
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Anthropometric and psychological changes
[Time Frame: 18 Months to 36 Months]
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Secondary ID(s)
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01072011FraMal
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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