Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight Infants

Study Overview
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Brief Summary
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In preterm infants with birth weights less than 1500 grams, does iron supplementation with 2mg/kg/day in addition to routine feeding with routine iron-fortified milk (formula or fortified mother's milk), as compared to routine iron fortified milk, increase hematocrit at 36 weeks adjusted postmenstrual age (or at discharge if sooner)?

Detailed Description
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Fortified mother's milk or fortified formula is routine practice in neonatal units and is not an intervention.

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

Conditions
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Iron Deficiency Anemia

Intervention / Treatment
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* Dietary Supplement: Iron Supplement
* Dietary Supplement: multivitamin


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 human 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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Minimum Age: 24 Weeks
Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: multivitamin with iron<br>daily oral multivitamin providing 2mg/kg of iron | Dietary Supplement: Iron Supplement<br>* multivitamin that provides 2mg/kg/day of iron given orally to infants when they are tolerating 120 ml/dg/day of preterm formula or fortified breast milk until they reach 36 weeks adjusted postmenstrual age.<br>* Other names: iron supplementation;|
| Placebo Comparator: multivitamin without iron<br>daily oral multivitamin without iron | Dietary Supplement: multivitamin<br>* daily oral multivitamin without iron until 36 weeks adjusted postmenstrual age<br>* Other names: Multivitamin without iron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematocrit (Hct) at 36 Wks Post Menstrual Age (PMA) | For infants discharged home prior to 36 wks PMA, the last Hct was used.For infants transferred prior to 36 wks PMA, the Hct at receiving hospital was used if available. A non-parametric rank sum analysis was performed as follows so that infants who died before 36 wks and those transfused could be included in an intention-to-treat analysis.Infants were ranked by death (lowest rank) then by number of transfusions (next lowest ranks). For infants who survived and were not transfused, the 36 wk PMA Hct was used as the primary outcome. | at 36 weeks adjusted postmenstrual age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Received Red Cell Transfusions During Intervention Period | The numbers below represent the number of participants in each arm that received a transfusion during intervention period. | from study day 1 to 36 week adjusted postmenstrual age or discharge if the infant is discharged sooner | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anemia, very low birth weight infants, iron supplementation