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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iron supplementation | Experimental | 2 mg/kg/day of elemental iron as a multivitamin with iron solution |
|
| control | Sham Comparator | multivitamin solution without iron |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron Supplement | Drug | 2 mg/kg/day elemental iron as multivitamin with iron solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 36 weeks postmenstrual age (PMA) |
| Measure | Description | Time Frame |
|---|---|---|
| Transfusions | # of transfusions infants required after enrollment. | enrollment to 36 weeks postmenstrual age (PMA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kennedy Kathleen, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23339225 | Result | 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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All groups started the study intervention once they had reached goal feedings of 120 cc/kg/day
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Iron Supplementation | 2 mg/kg/day of elemental iron as a multivitamin with iron solution |
| FG001 | Control | multivitamin solution without iron |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Iron Supplementation | 2 mg/kg/day of elemental iron as a multivitamin with iron solution |
| BG001 | Control | multivitamin solution 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 | Age is reported as postmenstrual age (PMA), which is the gestational age in weeks plus the postnatal age in weeks. |
| 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) | 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. | Posted | Mean | Standard Deviation | percentage of red blood cells in blood | 36 weeks postmenstrual age (PMA) |
|
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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 | Iron Supplementation | 2 mg/kg/day of elemental iron as a multivitamin with iron solution |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | Pregnancy, puerperium and perinatal conditions | Deaths are a possible and anticipated adverse event for this population. Neither death was related to study participation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathleen Kennedy | University of Texas Health Science Center - Houston | +1 (713) 500-5651 | Kathleen.A.Kennedy@uth.tmc.edu |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D007505 | Iron-Dextran Complex |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003911 | Dextrans |
| D005936 | Glucans |
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| control | Drug | multivitamin solution without iron |
|
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
multivitamin solution without iron
|
|
| Secondary | Transfusions | # of transfusions infants required after enrollment. | Posted | Median | Inter-Quartile Range | transfusions | enrollment to 36 weeks postmenstrual age (PMA) |
|
|
|
| 1 |
| 76 |
| 0 |
| 76 |
| EG001 | Control | multivitamin solution without iron | 1 | 74 | 0 | 74 |
|
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| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |