Iron Deficiency Anemia
Conditions
Keywords
very low birth weight infants, anemia, iron supplementation
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.
Interventions
DIETARY_SUPPLEMENTIron 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_SUPPLEMENTmultivitamin
daily oral multivitamin without iron until 36 weeks adjusted postmenstrual age
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
24 Weeks to 32 Weeks
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Multivitamin With Iron daily oral multivitamin providing 2mg/kg of iron | 76 |
| Multivitamin Without Iron daily oral multivitamin without iron | 74 |
| Total | 150 |
Baseline characteristics
| Characteristic | Multivitamin With Iron | Multivitamin Without Iron | Total |
|---|---|---|---|
| Age, Continuous | 27.3 gestational age (weeks) STANDARD_DEVIATION 2 | 27.3 gestational age (weeks) STANDARD_DEVIATION 2.1 | 27.3 gestational age (weeks) STANDARD_DEVIATION 2 |
| Region of Enrollment United States | 76 participants | 74 participants | 150 participants |
| Sex: Female, Male Female | 38 Participants | 35 Participants | 73 Participants |
| Sex: Female, Male Male | 38 Participants | 39 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 76 | 0 / 74 |
| serious Total, serious adverse events | 1 / 76 | 1 / 74 |
Outcome results
Primary
Hematocrit (Hct) at 36 Wks Post Menstrual Age (PMA)
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.
Time frame: at 36 weeks adjusted postmenstrual age
Population: Sample size was based on a retrospective observational pilot study from the 2008 calendar year. A sample size of 75 per group was chosen to achieve 80% power to detect a difference in Hct of 2 % between groups, assuming a mean Hct of 25.6% in the control group, a standard deviation 4.4%, with alpha level (0.05) using a two-sided two-sample t-test.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Multivitamin With Iron | Hematocrit (Hct) at 36 Wks Post Menstrual Age (PMA) | 29.2 % Hematocrit | Standard Deviation 4 |
| Multivitamin Without Iron | Hematocrit (Hct) at 36 Wks Post Menstrual Age (PMA) | 28.2 % Hematocrit | Standard Deviation 4.5 |
Comparison: A non-parametric rank sum analysis was performed as follows so that infants who died before 36 wks and infants who were 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 wks PMA Hct was used as the primary outcome.p-value: 0.59Wilcoxon (Mann-Whitney)
Secondary
Number of Participants Who Received Red Cell Transfusions During Intervention Period
The numbers below represent the number of participants in each arm that received a transfusion during intervention period.
Time frame: from study day 1 to 36 week adjusted postmenstrual age or discharge if the infant is discharged sooner
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Multivitamin With Iron | Number of Participants Who Received Red Cell Transfusions During Intervention Period | 48 participants |
| Multivitamin Without Iron | Number of Participants Who Received Red Cell Transfusions During Intervention Period | 54 participants |
Comparison: A non-parametric rank sum analysis was performed as follows so that infants who died before 36 wks and infants who were 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 wks PMA Hct was used as the primary outcome.p-value: 0.64Wilcoxon (Mann-Whitney)