Early Versus Late Enteral Iron in Infants Less Than 1301 Grams
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|ClinicalTrials.gov Identifier: NCT00458068|
Recruitment Status : Completed
First Posted : April 9, 2007
Last Update Posted : April 9, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Iron Deficiency Anemia of Prematurity||Drug: Oral administration of ferrous sulphate||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||126 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Prospective Randomized Trial of Early Versus Late Enteral Iron Supplementation in Infants With a Birth Weight of Less Than 1301 Grams|
|Study Start Date :||June 1996|
|Actual Study Completion Date :||September 1999|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00458068
|University Children's Hospital|
|Ulm, Germany, 89070|
|Principal Investigator:||Axel R Franz, MD||University of Ulm|