Iron Deficiency Clinical Trial
Official title:
Prospective Randomized Trial of Early Versus Late Enteral Iron Supplementation in Infants With a Birth Weight of Less Than 1301 Grams
Verified date | April 2007 |
Source | University of Ulm |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 126 |
Est. completion date | September 1999 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 7 Days |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Germany | University Children's Hospital | Ulm |
Lead Sponsor | Collaborator |
---|---|
University of Ulm |
Germany,
Franz AR, Mihatsch WA, Sander S, Kron M, Pohlandt F. Prospective randomized trial of early versus late enteral iron supplementation in infants with a birth weight of less than 1301 grams. Pediatrics. 2000 Oct;106(4):700-6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ferritin at 61 days of life | |||
Primary | The number of infants who fulfilled the criteria of ID at any time throughout the study. | |||
Secondary | Transferrin-Saturation | |||
Secondary | Hematocrit at day 61 | |||
Secondary | Reticulocyte count at day 61 | |||
Secondary | Mean corpuscular volume at day 61 | |||
Secondary | Mean corpuscular hemoglobin at day 61 | |||
Secondary | Number of infants who required transfusions at days 14 to 68 | |||
Secondary | Blood volume transfused at days 14 to 68 |
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