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Early Versus Late Enteral Iron in Infants Less Than 1301 Grams

Prospective Randomized Trial of Early Versus Late Enteral Iron Supplementation in Infants With a Birth Weight of Less Than 1301 Grams

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00458068
Enrollment
126
Registered
2007-04-09
Start date
1996-06-30
Completion date
1999-09-30
Last updated
2007-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia of Prematurity, Iron Deficiency

Keywords

preterm infant, iron supplementation, iron deficiency, blood transfusion

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.

Interventions

Sponsors

University of Ulm
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
3 Days to 7 Days
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

Design outcomes

Primary

MeasureTime frame
Ferritin at 61 days of life
The number of infants who fulfilled the criteria of ID at any time throughout the study.

Secondary

MeasureTime frame
Reticulocyte count at day 61
Mean corpuscular volume at day 61
Transferrin-Saturation
Number of infants who required transfusions at days 14 to 68
Blood volume transfused at days 14 to 68
Mean corpuscular hemoglobin at day 61
Hematocrit at day 61

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026