N/A
N=150
Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight Infants
Iron Deficiency Anemia
Bottom Line
View on ClinicalTrials.gov: NCT01125163 ↗Enrolled (actual)
150
Serious AEs
1.3%
Results posted
Jan 2019
Primary outcome: Primary: Hematocrit (Hct) at 36 Wks Post Menstrual Age (PMA) — 29.2; 28.2 % Hematocrit — p=0.59
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Iron Supplement (Dietary_supplement); multivitamin (Dietary_supplement)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Feb 2012
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 |
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)?
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
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.