- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00458068
Early Versus Late Enteral Iron in Infants Less Than 1301 Grams
Prospective Randomized Trial of Early Versus Late Enteral Iron Supplementation in Infants With a Birth Weight of Less Than 1301 Grams
Background: Preterm infants are at risk of iron deficiency. The smaller the infants are at birth, the smaller the iron stores at birth and the higher the risk of iron deficiency.
Hypothesis: Preterm infants with a birth weight of less than 1301g require iron supplementation earlier than previously recommended.
Methods: Prospective randomized controlled clinical trial (1996-1999). Results: Early iron supplementation may reduce the incidence of iron deficiency and the need for late blood transfusions.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ulm, Germany, 89070
- University Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Inborn infant
- Birth weight of <1301 g
- Admitted between June 1996 and June 1999
Exclusion Criteria:
- Major anomalies
- Hemolytic disease
- Twin-to-twin transfusion syndrome
- Missing parental consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Ferritin at 61 days of life
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The number of infants who fulfilled the criteria of ID at any time throughout the study.
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Secondary Outcome Measures
Outcome Measure |
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Transferrin-Saturation
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Hematocrit at day 61
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Reticulocyte count at day 61
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Mean corpuscular volume at day 61
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Mean corpuscular hemoglobin at day 61
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Number of infants who required transfusions at days 14 to 68
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Blood volume transfused at days 14 to 68
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Axel R Franz, MD, University of Ulm
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UL-NEO-IRON-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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