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Trial record 2 of 3 for:    "Anemia of Prematurity" | "Micronutrients"

Early Versus Late Enteral Iron in Infants Less Than 1301 Grams

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00458068
Recruitment Status : Completed
First Posted : April 9, 2007
Last Update Posted : April 9, 2007
Information provided by:
University of Ulm

Brief Summary:

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

Detailed Description:
Objectives. To examine whether early enteral iron supplementation (EI) would improve serum ferritin as a measure of nutritional iron status at 2 months of age and would prevent definite iron deficiency (ID) in infants with a birth weight of <1301 g. Methods. Infants were randomly assigned to receive enteral iron supplementation of 2 to 6 mg/kg/day as soon as enteral feedings of >100 mL/kg/day were tolerated (EI) or at 61 days of life (late enteral iron supplementation [LI]). Nutritional iron status was assessed: 1) at birth, 2) at 61 days of life, 3) when the infants reached a weight of 1.6 times birth weight, and 4) before blood was transfused at a hematocrit of <.25. ID was defined by any one of the following criteria: ferritin, <12 mg/L; transferrin saturation, <17%; or increase of absolute reticulocyte counts by >50% one week after the onset of enteral iron supplementation. Restrictive red cell transfusion guidelines were followed and all transfusions were documented. Erythropoietin was not administered. The primary outcome variables were: 1) ferritin at 61 days and 2) the number of infants with ID. Results. Ferritin at 61 days was not different between the groups. Infants in the LI group were more often iron-deficient (26/65 vs 10/68) and received more blood transfusions after day 14 of life. No adverse effects of EI were noted. Conclusions. EI is feasible and probably safe in infants with birth weight <1301 g. EI may reduce the incidence of ID and the number of late blood transfusions. ID may occur in very low birth weight infants despite early supplementation with iron and should be considered in the case of progressive anemia. Pediatrics 2000; 106:700 –706; preterm infant, iron supplementation, iron deficiency, blood transfusion.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
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
Study Start Date : June 1996
Actual Study Completion Date : September 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Primary Outcome Measures :
  1. Ferritin at 61 days of life
  2. The number of infants who fulfilled the criteria of ID at any time throughout the study.

Secondary Outcome Measures :
  1. Transferrin-Saturation
  2. Hematocrit at day 61
  3. Reticulocyte count at day 61
  4. Mean corpuscular volume at day 61
  5. Mean corpuscular hemoglobin at day 61
  6. Number of infants who required transfusions at days 14 to 68
  7. Blood volume transfused at days 14 to 68

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00458068

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University Children's Hospital
Ulm, Germany, 89070
Sponsors and Collaborators
University of Ulm
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Principal Investigator: Axel R Franz, MD University of Ulm

Publications of Results:
Layout table for additonal information Identifier: NCT00458068     History of Changes
Other Study ID Numbers: UL-NEO-IRON-1
First Posted: April 9, 2007    Key Record Dates
Last Update Posted: April 9, 2007
Last Verified: April 2007
Keywords provided by University of Ulm:
preterm infant
iron supplementation
iron deficiency
blood transfusion
Additional relevant MeSH terms:
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Trace Elements
Anemia, Iron-Deficiency
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Growth Substances
Physiological Effects of Drugs