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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: |
NCT00707785 |
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Date of registration:
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27/06/2008 |
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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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Effect of Vitamin A in the Treatment of Neonatal Sepsis and Necrotizing Enterocolitis
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Scientific title:
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Effect of Vitamin A in the Treatment of Sepsis and Necrotizing Enterocolitis in Hospitalized Neonates |
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Date of first enrolment:
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December 2006 |
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Target sample size:
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424 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00707785 |
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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: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Bangladesh
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Contacts
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Name:
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Christian L Coles, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Johns Hopkins Bloomberg School of Public Health |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- newborns less than 29 days with clinical sepsis
Exclusion Criteria:
- healthy infants
- major congenital abnormalities
- known inborn error(s) of metabolism
- chronic disorders of other organs (e.g. cholestasis)
- definite or severe NEC (> stage 2)
- congenital heart disease
- Infants receiving VA supplements
- Infants requiring mechanical ventilation
- Infant is unconscious
Age minimum:
N/A
Age maximum:
28 Days
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Meningitis
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Necrotizing Enterocolitis
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Sepsis
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Pneumonia
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Intervention(s)
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Dietary Supplement: Vitamin A
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Primary Outcome(s)
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Disease Mortality
[Time Frame: prospective]
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Secondary Outcome(s)
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Inflammatory cytokine concentration
[Time Frame: prospective]
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Duration of inflammation
[Time Frame: prospective]
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Disease progression in NEC patients
[Time Frame: prospective]
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Secondary ID(s)
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H.22.05.12.20.A2
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1K01DK075478-01
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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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