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

Phase 4CompletedNCT02060851

Kunshan First People's Hospital Affiliated to Jiangsu University96 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Malnutrition

Interventions

standard PNOTHER

Group 1: a control group who received standard PN

ViforDRUG

iron sucrose, 200 μg/kg per day, was given everyday with PN,

Vifor and EPODRUG

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

Eligibility

Sex: ALLMax age: 24 Hours

Medical Language ↔ Plain English

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

Locations (1)

Kunshan First Hospital

Kunshan, Jiangsu, China

Outcomes

Primary Outcomes

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.

Time frame: up to 2 weeks

Secondary Outcomes

Iron storage

Iron storage evaluation including ferritin, serum iron, TIBC on the days were measured before and after the intervention.

Time frame: up to 2 weeks

Data from ClinicalTrials.gov

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