Randomized Trial of Iron Supplementation to Prevent Anemia in Very-low-birth-weight Infants

The University of Texas System (UT)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Anemia

Treatments: Drug: Iron Supplement; Drug: control

Study type: Interventional

Funder types: Other

Identifiers

NCT01224236

RCT of Iron Supplementation

Details and patient eligibility

About

The purpose of this study is to determine if iron supplementation in addition to routine iron intake decreases the risk of developing anemia in preterm infants.

Full description

Objective was to determine if iron supplementation of 2 mg/kg per day, in addition to routine iron-fortified formula or mother's milk, increased the hematocrit (Hct) at 36 weeks' postmenstrual age (PMA).

All infants have a decline in hemoglobin(Hgb) after birth because of increasing PaO2 and Hgb saturation after birth. In very low birth weight (VLBW) infants (birth weight ,1500 g), the nadir at 1 to 3 months after birth is lower than in term infants because of (1) greater phlebotomy losses for blood tests, (2) shortened red blood cell survival, and (3)rapid growth.

VLBW infants may be at increased risk of developing iron deficiency anemia because of (1) low iron stores at birth, (2) rapid depletion of iron stores owing to phlebotomy losses, and (3) inability to regulate iron absorption by the gastrointestinal tract.

Enrollment: 150 patients

Sex: All

Ages: Under 8 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. birth weight: < 1500 grams
2. Tolerating iron fortified preterm formula or fortified breast milk at 120cc/kg/day by 8 weeks of age
3. ≤32 weeks adjusted post-menstrual age at the time of enrollment

Exclusion criteria

1. cyanotic heart disease
2. bowel resection prior to enrollment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups

iron supplementation

Experimental group

Description:

2 mg/kg/day of elemental iron as a multivitamin with iron solution

Treatment:

Drug: Iron Supplement

control

Sham Comparator group

Description:

multivitamin solution without iron

Treatment:

Drug: control