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Completed

NCT Number: NCT02060851

Effects of Early Short-term Intravenous Iron Supplements Combined EPO 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.

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Key information

Age range

Up to 24 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kunshan First Hospital

Kunshan, Jiangsu, 215300, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

standard PN

Other

Group 1: a control group who received standard PN

Other names: a control group

Vifor

Drug

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

Other names: an iron-supplemented group

Vifor and EPO

Drug

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

Primary outcomes

  1. Number of participants with Hematological evaluation

    Time frame: 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 outcomes

  1. Iron storage

    Time frame: up to 2 weeks

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

Sponsors and collaborators

Lead sponsor

Kunshan First People's Hospital Affiliated to Jiangsu University

Other

Registry information

Official study title

Effects of Early Parenteral Iron Combined Erythropoietin in Preterm Infants

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 12, 2014
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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