Early Versus Late Enteral Iron in Infants Less Than 1301 Grams

Iron Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00458068
• Other study ID #: UL-NEO-IRON-1
• Status: Completed
• Phase: N/A
• First received: April 6, 2007
• Last updated: April 6, 2007
• Start date: June 1996
• Est. completion date: September 1999

Study information

• Verified date: April 2007
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: September 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 7 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia of Prematurity
• Anemia, Iron-Deficiency
• Anemia, Neonatal
• Infant, Premature, Diseases
• Iron Deficiency

Intervention

Drug:
• Oral administration of ferrous sulphate

Locations

Country	Name	City	State
Germany	University Children's Hospital	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ferritin at 61 days of life
Primary	The number of infants who fulfilled the criteria of ID at any time throughout the study.
Secondary	Transferrin-Saturation
Secondary	Hematocrit at day 61
Secondary	Reticulocyte count at day 61
Secondary	Mean corpuscular volume at day 61
Secondary	Mean corpuscular hemoglobin at day 61
Secondary	Number of infants who required transfusions at days 14 to 68
Secondary	Blood volume transfused at days 14 to 68