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

The University of Texas System (UT)

Status: Completed

Conditions: Iron Deficiency Anemia

Treatments: Dietary Supplement: multivitamin; Dietary Supplement: Iron Supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT01125163

HSC-MS-10-0031

Details and patient eligibility

About

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)?

Full description

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

Enrollment: 150 patients

Sex: All

Ages: 24 to 32 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

multivitamin with iron

Active Comparator group

Description:

daily oral multivitamin providing 2mg/kg of iron

Treatment:

Dietary Supplement: Iron Supplement

multivitamin without iron

Placebo Comparator group

Description:

daily oral multivitamin without iron

Treatment:

Dietary Supplement: multivitamin