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

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ClinicalTrials.gov Identifier: NCT02060851
Recruitment Status : Unknown
Verified January 2014 by Wang Hua, Kunshan First People's Hospital Affiliated to Jiangsu University.
Recruitment status was:  Recruiting
First Posted : February 12, 2014
Last Update Posted : February 12, 2014
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 paediatric Parenteral nutrition suggested the dose of 200μg/kg.d iron by parenteral nutrition.In our early study serum ferritin and TIBC were not statistically significant before and after intervention by used the dose of intravenous iron.In our study,we find twhether iron combined EPO can improve iron state in preterm.

Condition or disease Intervention/treatment Phase
Preterm Anemia Drug: Iron sucrose Drug: EPO Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : February 2014
Estimated Primary Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Experimental: group 3
intravenous iron and EPO
Drug: Iron sucrose
Other Name: Cosmofer

Drug: EPO
Placebo Comparator: group 1
no intravenous iron or EPO
Experimental: group 2
intravenous iton but no EPO
Drug: Iron sucrose
Other Name: Cosmofer




Primary Outcome Measures :
  1. Hematological evaluation [ Time Frame: up to 2 weeks ]
    Hematological evaluation including RBC, Hb, MCV, MCH, MCHC, RET, CRP were mesured 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


Contacts
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Contact: Hua Wang, MD 0512-57027091 mumeer@126.com

Locations
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China, Jiangsu
Kunshan First Hospital Recruiting
Kunshan, ,, Jiangsu, China, 215300
Contact: Hua Wang, MD    +8618913261020    mumeer@126.com   
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     History of Changes
Other Study ID Numbers: kunshan002
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: February 12, 2014
Last Verified: January 2014

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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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Iron
Ferric Oxide, Saccharated
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics