NCT01125163

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 24 Weeks – 32 Weeks
• Healthy volunteers: Accepted

Summary

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

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

Conditions

• Iron Deficiency Anemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Iron 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.
DIETARY_SUPPLEMENT	multivitamin	daily oral multivitamin without iron until 36 weeks adjusted postmenstrual age

Timeline

• Start date: 2010-05-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2010-05-18
• Last updated: 2019-01-04
• Results posted: 2019-01-04

Locations

1 site across 1 country: United States