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

Primary Purpose

Malnutrition

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

standard PN

Vifor

Vifor and EPO

About this trial

This is an interventional treatment trial for Malnutrition focused on measuring EPO, Intravenous iron, iron storage, preterm anemia

Eligibility Criteria

undefined - 24 Hours (Child)All SexesDoes not accept 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

Sites / Locations

Kunshan First Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Vifor and EPO

control

Vifor

Arm Description

intravenous iron and EPO

no intravenous iron or EPO

intravenous iton but no EPO

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Iron storage

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

Full Information

NCT ID

NCT02060851

First Posted

February 9, 2014

Last Updated

February 24, 2020

Sponsor

Kunshan First People's Hospital Affiliated to Jiangsu University

1. Study Identification

Unique Protocol Identification Number

NCT02060851

Brief Title

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

Official Title

Effects of Early Parenteral Iron Combined Erythropoietin in Preterm Infants

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

February 2014 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kunshan First People's Hospital Affiliated to Jiangsu University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malnutrition

Keywords

EPO, Intravenous iron, iron storage, preterm anemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

96 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vifor and EPO

Arm Type

Experimental

Arm Description

intravenous iron and EPO

Arm Title

control

Arm Type

Placebo Comparator

Arm Description

no intravenous iron or EPO

Arm Title

Vifor

Arm Type

Experimental

Arm Description

intravenous iton but no EPO

Intervention Type

Other

Intervention Name(s)

standard PN

Other Intervention Name(s)

a control group

Intervention Description

Group 1: a control group who received standard PN

Intervention Type

Drug

Intervention Name(s)

Vifor

Other Intervention Name(s)

an iron-supplemented group

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Vifor and EPO

Other Intervention Name(s)

iron-supplemented combined EPO group

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of participants with Hematological evaluation

Description

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 Outcome Measure Information:

Title

Iron storage

Description

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

Time Frame

up to 2 weeks

10. Eligibility

Sex

All

Maximum Age & Unit of Time

24 Hours

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Kunshan First Hospital

City

Kunshan, ,

State/Province

Jiangsu

ZIP/Postal Code

215300

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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

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