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

K

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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