Early Versus Late Enteral Iron in Infants Less Than 1301 Grams

This study has been completed.
Sponsor:
Information provided by:
University of Ulm
ClinicalTrials.gov Identifier:
NCT00458068
First received: April 6, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  Purpose

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 Intervention
Iron Deficiency
Anemia of Prematurity
Drug: Oral administration of ferrous sulphate

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Ulm:

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

Secondary Outcome Measures:
  • Transferrin-Saturation
  • 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

Estimated Enrollment: 126
Study Start Date: June 1996
Study Completion Date: September 1999
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.

  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00458068

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

Publications:
ClinicalTrials.gov Identifier: NCT00458068     History of Changes
Other Study ID Numbers: UL-NEO-IRON-1
Study First Received: April 6, 2007
Last Updated: April 6, 2007
Health Authority: Germany: Ethics Commission

Keywords provided by University of Ulm:
preterm infant
iron supplementation
iron deficiency
blood transfusion

Additional relevant MeSH terms:
Anemia
Anemia, Neonatal
Infant, Premature, Diseases
Anemia, Iron-Deficiency
Hematologic Diseases
Infant, Newborn, Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 31, 2014