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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: |
NCT01224236 |
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Date of registration:
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14/10/2010 |
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Primary sponsor: |
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Public title:
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Randomized Trial of Iron Supplementation to Prevent Anemia in Very-low-birth-weight Infants
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Scientific title:
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Randomized Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight (VLBW) Infants |
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Date of first enrolment:
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July 2010 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01224236 |
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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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Countries of recruitment
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United States
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Contacts
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Name:
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Kennedy Kathleen, 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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The University of Texas Health Science Center, Houston |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. birth weight: < 1500 grams
2. Tolerating iron fortified preterm formula or fortified breast milk at 120cc/kg/day by
8 weeks of age
3. =32 weeks adjusted post-menstrual age at the time of enrollment
Exclusion Criteria:
1. cyanotic heart disease
2. bowel resection prior to enrollment
Age minimum:
N/A
Age maximum:
8 Weeks
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anemia
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Intervention(s)
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Drug: control
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Drug: Iron Supplement
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Primary Outcome(s)
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Plasma hematocrit at 36 weeks postmenstrual age
[Time Frame: 36 weeks postmenstrual age]
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Secondary ID(s)
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RCT of Iron Supplementation
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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