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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-02-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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iron supplementation

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

Group Type EXPERIMENTAL

Iron Supplement

Intervention Type DRUG

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

control

multivitamin solution without iron

Group Type SHAM_COMPARATOR

control

Intervention Type DRUG

multivitamin solution without iron

Interventions

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Iron Supplement

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

Intervention Type DRUG

control

multivitamin solution without iron

Intervention Type DRUG

Eligibility Criteria

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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