Early Versus Late Enteral Iron in Infants Less Than 1301 Grams
Primary Purpose
Iron Deficiency, Anemia of Prematurity
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Oral administration of ferrous sulphate
Sponsored by
About this trial
This is an interventional prevention trial for Iron Deficiency focused on measuring preterm infant, iron supplementation, iron deficiency, blood transfusion
Eligibility 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
Sites / Locations
- University Children's Hospital
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00458068
Brief Title
Early Versus Late Enteral Iron in Infants Less Than 1301 Grams
Official Title
Prospective Randomized Trial of Early Versus Late Enteral Iron Supplementation in Infants With a Birth Weight of Less Than 1301 Grams
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
June 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 1999 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Ulm
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency, Anemia of Prematurity
Keywords
preterm infant, iron supplementation, iron deficiency, blood transfusion
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
126 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Oral administration of ferrous sulphate
Primary Outcome Measure Information:
Title
Ferritin at 61 days of life
Title
The number of infants who fulfilled the criteria of ID at any time throughout the study.
Secondary Outcome Measure Information:
Title
Transferrin-Saturation
Title
Hematocrit at day 61
Title
Reticulocyte count at day 61
Title
Mean corpuscular volume at day 61
Title
Mean corpuscular hemoglobin at day 61
Title
Number of infants who required transfusions at days 14 to 68
Title
Blood volume transfused at days 14 to 68
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Days
Maximum Age & Unit of Time
7 Days
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Axel R Franz, MD
Organizational Affiliation
University of Ulm
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Children's Hospital
City
Ulm
ZIP/Postal Code
89070
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
11015511
Citation
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. doi: 10.1542/peds.106.4.700.
Results Reference
result
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Early Versus Late Enteral Iron in Infants Less Than 1301 Grams
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