Early Versus Late Enteral Iron in Infants Less Than 1301 Grams

NCT ID: NCT00458068

Last Updated: 2007-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-06-30
• Study Completion Date: 1999-09-30

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.

Conditions

Iron Deficiency; Anemia of Prematurity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Interventions

Oral administration of ferrous sulphate

Intervention Type: DRUG

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

• Minimum Eligible Age: 3 Days
• Maximum Eligible Age: 7 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ulm

OTHER

Sponsor Role: lead

Principal Investigators

Axel R Franz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Ulm

Locations

University Children's Hospital

Ulm, , Germany

Countries

Germany

References

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.

Reference Type: RESULT

PMID: 11015511 (View on PubMed)

Other Identifiers

UL-NEO-IRON-1

Identifier Type: -

Identifier Source: org_study_id