N/A Completed N=150 Randomized Quadruple-blind Supportive Care

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

Iron Deficiency Anemia

Source: ClinicalTrials.gov NCT01125163 ↗

Enrolled (actual)

150

Serious AEs

1.3%

Results posted

Jan 2019

Primary outcomePrimary: Hematocrit (Hct) at 36 Wks Post Menstrual Age (PMA) — 29.2; 28.2 % Hematocrit — p=0.59

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)?

Outcome Measures

Outcome	Result	p-value
PRIMARY Hematocrit (Hct) at 36 Wks Post Menstrual Age (PMA)	29.2; 28.2	0.59
SECONDARY Number of Participants Who Received Red Cell Transfusions During Intervention Period	48; 54	0.64

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01125163). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.