Effects of Early Short-term Intravenous Iron Supplements Combined EPO in Preterm Infants

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Effects of Early Parenteral Iron Combined Erythropoietin in Preterm Infants

Conditions
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Malnutrition

Intervention / Treatment
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* Other: standard PN
* Drug: Vifor
* Drug: Vifor and EPO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm infants with birth weight less than 2.5kg Have parenteral nutrition indication With written informed consent of parents or guardian Exclusion Criteria: Kidney and liver function abnormal have hemolytic disease have hemorrhagic disease have Serious congenital malformation have septicemia have plethora newborn use TPN less than ten days

Ages Eligible for Study
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Maximum Age: 24 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vifor and EPO<br>intravenous iron and EPO | Drug: Vifor and EPO<br>* 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<br>* Other names: iron-supplemented combined EPO group;|
| Placebo Comparator: control<br>no intravenous iron or EPO | Other: standard PN<br>* Group 1: a control group who received standard PN<br>* Other names: a control group;|
| Experimental: Vifor<br>intravenous iton but no EPO | Drug: Vifor<br>* iron sucrose, 200 μg/kg per day, was given everyday with PN,<br>* Other names: an iron-supplemented group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EPO, Intravenous iron, iron storage, preterm anemia