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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)?
Fortified mother's milk or fortified formula is routine practice in neonatal units and is not an intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| multivitamin with iron | Active Comparator | daily oral multivitamin providing 2mg/kg of iron |
|
| multivitamin without iron | Placebo Comparator | daily oral multivitamin without iron |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron Supplement | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 36 weeks adjusted postmenstrual age |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from study day 1 to 36 week adjusted postmenstrual age or discharge if the infant is discharged sooner |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tiffany Taylor, M.D. | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Memorial Hermann Hospital, Texas Medical Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23339225 | Derived | Taylor TA, Kennedy KA. Randomized trial of iron supplementation versus routine iron intake in VLBW infants. Pediatrics. 2013 Feb;131(2):e433-8. doi: 10.1542/peds.2012-1822. Epub 2013 Jan 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Multivitamin With Iron | daily oral multivitamin providing 2mg/kg of iron |
| FG001 | Multivitamin Without Iron | daily oral multivitamin without iron |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Multivitamin With Iron | daily oral multivitamin providing 2mg/kg of iron |
| BG001 | Multivitamin Without Iron | daily oral multivitamin without iron |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Infants with birth weight <1500 g who reached 120 ml/kg/day of feedings prior to 32 wks postmenstrual age were eligible. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | % Hematocrit | at 36 weeks adjusted postmenstrual age |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Multivitamin With Iron | daily oral multivitamin providing 2mg/kg of iron |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Gastrointestinal disorders | Systematic Assessment | The two infants (one in each group) died of Necrotizing Entercolitis which is an illness that occurs in extremely premature infants. |
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This trial was done in a setting where relatively liberal transfusion guidelines (based on PINT study) are used so difficult to generalize to settings where restrictive transfusion guidelines are used.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kathleen A. Kennedy | UTexas_Houston | 713-500-6708 | Kathleen.A.Kennedy@uth.tmc.edu |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000090463 | Iron Deficiencies |
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| ID | Term |
|---|---|
| D007505 | Iron-Dextran Complex |
| C067316 | Geritol |
| D007501 | Iron |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003911 | Dextrans |
| D005936 | Glucans |
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|
| multivitamin | Dietary Supplement | daily oral multivitamin without iron until 36 weeks adjusted postmenstrual age |
|
|
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| gestational age (weeks) |
|
| Sex: Female, Male | number of females and males per group (intervention and control) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Multivitamin With Iron |
daily oral multivitamin providing 2mg/kg/day of iron |
| OG001 | Multivitamin Without Iron | daily oral multivitamin without iron |
|
|
|
| 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. | Posted | Number | participants | from study day 1 to 36 week adjusted postmenstrual age or discharge if the infant is discharged sooner |
|
|
|
|
| 1 |
| 76 |
| 0 |
| 76 |
| EG001 | Multivitamin Without Iron | daily oral multivitamin without iron | 1 | 74 | 0 | 74 |
|
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| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |