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

The University of Texas Health Science Center, Houston150 enrolled

Overview

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)?

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

150

Conditions

Iron Deficiency Anemia

Interventions

Iron SupplementDIETARY_SUPPLEMENT

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.

multivitaminDIETARY_SUPPLEMENT

daily oral multivitamin without iron until 36 weeks adjusted postmenstrual age

Eligibility

Sex: ALLMin age: 24 WeeksMax age: 32 WeeksHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Children's Memorial Hermann Hospital, Texas Medical Center

Houston, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: at 36 weeks adjusted postmenstrual age

Secondary Outcomes

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.

Time frame: from study day 1 to 36 week adjusted postmenstrual age or discharge if the infant is discharged sooner

Data from ClinicalTrials.gov

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