Malnutrition
Conditions
Keywords
EPO, Intravenous iron, iron storage, preterm anemia
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.
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).
Interventions
OTHERstandard PN
Group 1: a control group who received standard PN
DRUGVifor
iron sucrose, 200 μg/kg per day, was given everyday with PN,
DRUGVifor 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
Sponsors
Kunshan First People's Hospital Affiliated to Jiangsu University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 24 Hours
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Hematological evaluation | 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
| Measure | Time frame | Description |
|---|---|---|
| Iron storage | up to 2 weeks | Iron storage evaluation including ferritin, serum iron, TIBC on the days were measured before and after the intervention. |
Countries
China
Outcome results
None listed