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CompletedNCT00458068Updated Apr 9, 2007

Early Versus Late Enteral Iron in Infants Less Than 1301 Grams

An interventional study of Oral administration of ferrous sulphate in Iron Deficiency and Anemia of Prematurity, sponsored by University of Ulm. Completed at 1 site in Germany. Open to participants aged 3 Days to 7 Days. Per ClinicalTrials.gov, last updated 2007-04-09.

Sponsored by University of Ulm · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
3 Days to 7 Days
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Iron Deficiency
  • Anemia of Prematurity

Keywords

  • preterm infant
  • iron supplementation
  • iron deficiency
  • blood transfusion
03

In context

Anemia, Iron-Deficiency

644 studies on the registry are indexed under Anemia, Iron-Deficiency; 105 are open to participants now.

This study's enrollment of 126 is above the median of 100 across 503 interventional studies indexed under Anemia, Iron-Deficiency.

Browse Anemia, Iron-Deficiency studies →

Lead sponsor

University of Ulm is the lead sponsor of 141 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Days to 7 Days
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Inborn infant
  • Birth weight of \<1301 g
  • Admitted between June 1996 and June 1999

Exclusion criteria

Exclusion Criteria:

  • Major anomalies
  • Hemolytic disease
  • Twin-to-twin transfusion syndrome
  • Missing parental consent
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
Single
Enrollment
126 participants

Interventions

  • DrugOral administration of ferrous sulphate
06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • University Children's Hospital
    Ulm, 89070, Germany
08

References and documents

Publications

  • 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. PubMed 11015511 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00458068
Lead sponsor
University of Ulm
First posted
Apr 9, 2007
Start date
Jun 1996
Completion
Sep 1999
Last update
Apr 9, 2007

Study contacts

Axel R Franz, MD
principal investigator · University of Ulm

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.

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