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

Effects of Early Parenteral Iron Combined Erythropoietin in Preterm Infants

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.

Study Overview

• Status: Completed
• Conditions: Malnutrition
• Intervention / Treatment: Drug: Vifor and EPO; Other: standard PN; Drug: Vifor

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 Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Kunshan, ,, Jiangsu, China, 215300
      • Kunshan First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 day (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vifor and EPO; intravenous iron and EPO	Drug: Vifor and EPO; 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; Other Names: iron-supplemented combined EPO group
Placebo Comparator: control; no intravenous iron or EPO	Other: standard PN; Group 1: a control group who received standard PN; Other Names: a control group
Experimental: Vifor; intravenous iton but no EPO	Drug: Vifor; iron sucrose, 200 μg/kg per day, was given everyday with PN,; Other Names: an iron-supplemented group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 2 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kunshan First People's Hospital Affiliated to Jiangsu University

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: February 9, 2014
• First Submitted That Met QC Criteria: February 9, 2014
• First Posted (Estimate): February 12, 2014

Study Record Updates

• Last Update Posted (Actual): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 24, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: EPO; Intravenous iron; iron storage; preterm anemia
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Physiological Effects of Drugs; Trace Elements; Micronutrients; Iron
• Other Study ID Numbers: kunshan002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO