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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02060851
Recruitment Status : Completed
First Posted : February 12, 2014
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Wang Hua, 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.

Condition or disease Intervention/treatment Phase
Malnutrition Other: standard PN Drug: Vifor Drug: Vifor and EPO Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Early Parenteral Iron Combined Erythropoietin in Preterm Infants
Study Start Date : February 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

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 Name: 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 Name: 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 Name: an iron-supplemented group




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060851


Locations
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China, Jiangsu
Kunshan First Hospital
Kunshan, ,, Jiangsu, China, 215300
Sponsors and Collaborators
Kunshan First People's Hospital Affiliated to Jiangsu University
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Responsible Party: Wang Hua, Ethics Committee of Kunshan First People's Hospital, Kunshan First People's Hospital Affiliated to Jiangsu University
ClinicalTrials.gov Identifier: NCT02060851    
Other Study ID Numbers: kunshan002
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Wang Hua, Kunshan First People's Hospital Affiliated to Jiangsu University:
EPO
Intravenous iron
iron storage
preterm anemia
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders
Iron
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs