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

Phase 4

Completed

• Conditions: Malnutrition
• Interventions: Other: standard PN; Drug: Vifor and EPO; Drug: Vifor

• Registration Number: NCT02060851
• Lead Sponsor: Kunshan First People's Hospital Affiliated to Jiangsu University

Brief Summary

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

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 Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-09
• Study First Submitted QC: 2014-02-09
• Study First Posted: 2014-02-12
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	standard PN	no intravenous iron or EPO
Vifor and EPO	Vifor and EPO	intravenous iron and EPO
Vifor	Vifor	intravenous iton but no EPO

Primary Outcome Measures

Name	Time	Method
Number of participants with Hematological evaluation	up to 2 weeks	Hematological evaluation including RBC, Hb, MCV, MCH, MCHC, RET, CRP were measured before and after the intervention. The three groups were all peripheral blood.

Secondary Outcome Measures

Name	Time	Method
Iron storage	up to 2 weeks	Iron storage evaluation including ferritin, serum iron, TIBC on the days were measured before and after the intervention.

Trial Locations

Locations (1)

Kunshan First Hospital; 🇨🇳 Kunshan, ,, Jiangsu, China