Phase 3
Completed N=150
Randomized Trial of Iron Supplementation to Prevent Anemia in Very-low-birth-weight Infants
Source: ClinicalTrials.gov NCT01224236 ↗Enrolled (actual)
150
Serious AEs
1.3%
Results posted
Jun 2015
Primary outcomePrimary: Hematocrit (Hct) — 29.2; 28.3 percentage of red blood cells in blood
Summary
The purpose of this study is to determine if iron supplementation in addition to routine iron intake decreases the risk of developing anemia in preterm infants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hematocrit (Hct) |
29.2; 28.3 | — |
| SECONDARY Transfusions |
1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- birth weight: < 1500 grams
- Tolerating iron fortified preterm formula or fortified breast 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
Data sourced from ClinicalTrials.gov (NCT01224236). 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.