Effects of Early Short-term Intravenous Iron Supplements Combined EPO in Preterm Infants
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|ClinicalTrials.gov Identifier: NCT02060851|
Recruitment Status : Completed
First Posted : February 12, 2014
Last Update Posted : February 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Malnutrition||Other: standard PN Drug: Vifor Drug: Vifor and EPO||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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
intravenous iton but no EPO
iron sucrose, 200 μg/kg per day, was given everyday with PN,
Other Name: an iron-supplemented group
- 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.
- 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.
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
|Kunshan First Hospital|
|Kunshan, ,, Jiangsu, China, 215300|