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

Study Overview
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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.

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.

Official Title
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Randomized Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight (VLBW) Infants

Conditions
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Anemia

Intervention / Treatment
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* Drug: Iron Supplement
* Drug: control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: birth weight: < 1500 grams Tolerating iron fortified preterm formula or fortified breast milk at 120cc/kg/day by 8 weeks of age ≤32 weeks adjusted post-menstrual age at the time of enrollment Exclusion Criteria: cyanotic heart disease bowel resection prior to enrollment

Ages Eligible for Study
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Maximum Age: 8 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iron supplementation<br>2 mg/kg/day of elemental iron as a multivitamin with iron solution | Drug: Iron Supplement<br>* 2 mg/kg/day elemental iron as multivitamin with iron solution<br>|
| Sham Comparator: control<br>multivitamin solution without iron | Drug: control<br>* multivitamin solution without iron<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematocrit (Hct) | For infants discharged from the hospital before 36 weeks' postmenstrual age (PMA), the last Hct before discharge was used. For infants transferred before 36 weeks PMA, the Hct at 36 weeks was sought from the receiving hospital and used if available. For infants transferred before 36 weeks with no available Hct at 36 weeks, the last Hct before transfer was used. For those who died before 36 weeks PMA, the Hct at 36 weeks was considered to be missing. | 36 weeks postmenstrual age (PMA) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfusions | # of transfusions infants required after enrollment. | enrollment to 36 weeks postmenstrual age (PMA) |