Early Versus Late Enteral Iron in Infants 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.
Anemia of Prematurity
Drug: Oral administration of ferrous sulphate
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Prevention
|Official Title:||Prospective Randomized Trial of Early Versus Late Enteral Iron Supplementation in Infants With a Birth Weight of Less Than 1301 Grams|
- Ferritin at 61 days of life
- The number of infants who fulfilled the criteria of ID at any time throughout the study.
- Hematocrit at day 61
- Reticulocyte count at day 61
- Mean corpuscular volume at day 61
- Mean corpuscular hemoglobin at day 61
- Number of infants who required transfusions at days 14 to 68
- Blood volume transfused at days 14 to 68
|Study Start Date:||June 1996|
|Study Completion Date:||September 1999|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00458068
|University Children's Hospital|
|Ulm, Germany, 89070|
|Principal Investigator:||Axel R Franz, MD||University of Ulm|