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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00134771 |
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Date of registration:
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24/08/2005 |
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Primary sponsor: |
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Public title:
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Trial of Nutritional Supplementation in Infants Born Small for Gestational Age
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Scientific title:
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Date of first enrolment:
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February 2001 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00134771 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Educational/Counseling/Training
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Atul Singhal |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institute of Child Health |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Infants who are formula fed from birth
- Infants whose birthweights are less than 20th centile
- Singleton births
- Gestation > 37 weeks
- Infants free from major congenital disease
Exclusion Criteria:
- Infants who are breast-fed
- Multiple births
- Birthweight > 20th centile
- Infants with congenital disease
- Gestation < 37 weeks
Age minimum:
N/A
Age maximum:
10 Days
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Birth Weight
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Intervention(s)
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Drug: Nutrient enriched infant formula
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Primary Outcome(s)
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Weight, length, head circumference at 6 months
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Secondary Outcome(s)
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Blood pressure at six months
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Body composition at 6 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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