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

Kunshan First People's Hospital Affiliated to Jiangsu University

Status and phase: Completed; Phase 4

Conditions: Malnutrition

Treatments: Drug: Vifor; Drug: Vifor and EPO; Other: standard PN

Study type: Interventional

Funder types: Industry

Identifiers

NCT02060851

kunshan002

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 96 patients

Sex: All

Ages: Under 24 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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96 participants in 3 patient groups, including a placebo group

Vifor and EPO

Experimental group

Description:

intravenous iron and EPO

Treatment:

Drug: Vifor and EPO

control

Placebo Comparator group

Description:

no intravenous iron or EPO

Treatment:

Other: standard PN

Vifor

Experimental group

Description:

intravenous iton but no EPO

Treatment:

Drug: Vifor