Clinical trial NCT00458068: 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
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency
Anemia of Prematurity
Keywords: preterm infant
iron supplementation
iron deficiency
blood transfusion
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2007-04-09
Enrollment: 126
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Ferritin at 61 days of life
measure: The number of infants who fulfilled the criteria of ID at any time throughout the study.
Secondary outcomes:
measure: Transferrin-Saturation
measure: Hematocrit at day 61
measure: Reticulocyte count at day 61
measure: Mean corpuscular volume at day 61
measure: Mean corpuscular hemoglobin at day 61
measure: Number of infants who required transfusions at days 14 to 68
measure: Blood volume transfused at days 14 to 68
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: University Children's Hospital
Study officials:
affiliation: University of Ulm
name: Axel R Franz, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.