Anemia
Conditions
Brief 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.
Detailed description
Objective was to determine if iron supplementation of 2 mg/kg per day, in addition to routine iron-fortified formula or mother's milk, increased the hematocrit (Hct) at 36 weeks' postmenstrual age (PMA). All infants have a decline in hemoglobin(Hgb) after birth because of increasing PaO2 and Hgb saturation after birth. In very low birth weight (VLBW) infants (birth weight ,1500 g), the nadir at 1 to 3 months after birth is lower than in term infants because of (1) greater phlebotomy losses for blood tests, (2) shortened red blood cell survival, and (3)rapid growth. VLBW infants may be at increased risk of developing iron deficiency anemia because of (1) low iron stores at birth, (2) rapid depletion of iron stores owing to phlebotomy losses, and (3) inability to regulate iron absorption by the gastrointestinal tract.
Interventions
DRUGIron Supplement
2 mg/kg/day elemental iron as multivitamin with iron solution
DRUGcontrol
multivitamin solution without iron
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 8 Weeks
Healthy volunteers
No
Inclusion criteria
1. birth weight: \< 1500 grams 2. Tolerating iron fortified preterm formula or fortified breast milk at 120cc/kg/day by 8 weeks of age 3. ≤32 weeks adjusted post-menstrual age at the time of enrollment
Exclusion criteria
1. cyanotic heart disease 2. bowel resection prior to enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hematocrit (Hct) | 36 weeks postmenstrual age (PMA) | For infants discharged from the hospital before 36 weeks' postmenstrual age (PMA), the last Hct before discharge was used. For infants transferred before 36 weeks PMA, the Hct at 36 weeks was sought from the receiving hospital and used if available. For infants transferred before 36 weeks with no available Hct at 36 weeks, the last Hct before transfer was used. For those who died before 36 weeks PMA, the Hct at 36 weeks was considered to be missing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transfusions | enrollment to 36 weeks postmenstrual age (PMA) | \# of transfusions infants required after enrollment. |
Countries
United States
Participant flow
Recruitment details
Infants were screened by birth weight on admission to the neonatal intensive care unit (NICU). If birth weight criteria were met, infants were followed to see if they met eligibility criteria. If they approached eligibility, parents were approached for consent by the investigator. IRB approved to recruit 4/6/2010. Enrollment completed by 10/2012.
Pre-assignment details
All groups started the study intervention once they had reached goal feedings of 120 cc/kg/day
Participants by arm
| Arm | Count |
|---|---|
| Iron Supplementation 2 mg/kg/day of elemental iron as a multivitamin with iron solution | 76 |
| Control multivitamin solution without iron | 74 |
| Total | 150 |
Baseline characteristics
| Characteristic | Iron Supplementation | Control | Total |
|---|---|---|---|
| Age, Continuous | 29.7 weeks STANDARD_DEVIATION 1.5 | 29.7 weeks STANDARD_DEVIATION 1.4 | 29.7 weeks STANDARD_DEVIATION 1.5 |
| 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)
For infants discharged from the hospital before 36 weeks' postmenstrual age (PMA), the last Hct before discharge was used. For infants transferred before 36 weeks PMA, the Hct at 36 weeks was sought from the receiving hospital and used if available. For infants transferred before 36 weeks with no available Hct at 36 weeks, the last Hct before transfer was used. For those who died before 36 weeks PMA, the Hct at 36 weeks was considered to be missing.
Time frame: 36 weeks postmenstrual age (PMA)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Iron Supplementation | Hematocrit (Hct) | 29.2 percentage of red blood cells in blood | Standard Deviation 4 |
| Control | Hematocrit (Hct) | 28.3 percentage of red blood cells in blood | Standard Deviation 4.5 |
Secondary
Transfusions
\# of transfusions infants required after enrollment.
Time frame: enrollment to 36 weeks postmenstrual age (PMA)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Iron Supplementation | Transfusions | 1 transfusions |
| Control | Transfusions | 1 transfusions |