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There are wide variations in iron supplementation practices in NICU.Guidelines on pediatric Parenteral nutrition suggested the dose of 200μg/kg.d iron by parenteral nutrition.
The study was approved by the ethics committee of Xinhua Hospital, and all parents gave written informed consent.
Study Design This was a randomized, controlled, double-blind, interventional trial of iron (iron sucrose) supplementation given from age of 1 day until full 2 weeks to preterm infants in NICU, who divided into three groups, control(PN without iron and EPO), Vifor and vifor and EPOE group, according to the recommended dosage of ESPEN .
Outcome Measures General information and indicators including anemia iron storage were measured. And the same time oxidative stress indicators were monitored at age of 1day and 2 weeks.
General growth parameters including the blood sugar, liver and renal function index before and after the intervention were tested.
Hematological evaluation including RBC, Hb, MCV, MCH, MCHC, RET, CRP were mesured before and after the intervention. The three groups were all peripheral blood.
Iron storage evaluation including ferritin, serum iron, TIBC on the days were measured before and after the intervention. We used the radio-immunoassay method to test the ferritin (DADE BEHRING, Germany), the chemical method to the serum iron and the automatic biochemical analyzer (automatic biochemical analyzer, 7600, HITACH).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vifor and EPO | Experimental | intravenous iron and EPO |
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| control | Placebo Comparator | no intravenous iron or EPO |
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| Vifor | Experimental | intravenous iton but no EPO |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard PN | Other | Group 1: a control group who received standard PN |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Hematological evaluation | Hematological evaluation including RBC, Hb, MCV, MCH, MCHC, RET, CRP were measured before and after the intervention. The three groups were all peripheral blood. | up to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Iron storage | Iron storage evaluation including ferritin, serum iron, TIBC on the days were measured before and after the intervention. | up to 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kunshan First Hospital | Kunshan | Jiangsu | 215300 | China |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Vifor | Drug | iron sucrose, 200 μg/kg per day, was given everyday with PN, |
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| Vifor and EPO | Drug | EPO, 400U/kg, was given twice a week (Monday and Friday). IS, 200 μg/kg per day, was given everyday with PN, and the dose was continued until 2 weeks after birth |
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