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

Not Applicable

Completed

• Conditions: Iron Deficiency Anemia
• Interventions: Dietary Supplement: multivitamin; Dietary Supplement: Iron Supplement

• Registration Number: NCT01125163
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief 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.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-13
• Study First Submitted QC: 2010-05-17
• Study First Posted: 2010-05-18
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Results First Submitted: 2012-03-18
• Status Verified: 2018-07
• Results First Submitted QC: 2018-07-10
• Last Update Submitted: 2018-07-10
• Results First Posted: 2019-01-04
• Last Update Posted: 2019-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
multivitamin without iron	multivitamin	daily oral multivitamin without iron
multivitamin with iron	Iron Supplement	daily oral multivitamin providing 2mg/kg of iron

Primary Outcome Measures

Name	Time	Method
Hematocrit (Hct) at 36 Wks Post Menstrual Age (PMA)	at 36 weeks adjusted postmenstrual age	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Children's Memorial Hermann Hospital, Texas Medical Center; 🇺🇸 Houston, Texas, United States