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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: |
NCT01850784 |
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Date of registration:
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07/05/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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High Energy Formula Feeding in Infants With Congenital Heart Disease
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Scientific title:
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High Energy Formula Feeding in Infants With Congenital Heart Disease |
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Date of first enrolment:
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February 2013 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01850784 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
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Phase:
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N/A
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Countries of recruitment
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Turkey
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Contacts
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Name:
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Dilek Dilli |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sami Ulus CH |
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Name:
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Nazan N Dogan, 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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Name:
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Dilek Dilli, Assoc Prof |
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Address:
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Telephone:
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00903126243 |
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Email:
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dilekdilli2@yahoo.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- infants >35 weeks of gestational age
- infants with CHD
- Infants fed with formula feeding
Exclusion Criteria:
- Major congenital abnormalities except CHD
- infants could not be fed enterally
Age minimum:
N/A
Age maximum:
6 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Neurodevelopmental Disorder
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Growth Failure
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Intervention(s)
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Dietary Supplement: High energy formula
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Dietary Supplement: Standard formula
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Primary Outcome(s)
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Weight gain
[Time Frame: 6 weeks]
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Secondary Outcome(s)
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Neurodevelopmental evaluation
[Time Frame: 18 months]
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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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