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

Malnutrition Clinical Trial

Official title:

Effects of Early Parenteral Iron Combined Erythropoietin in Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02060851
• Other study ID #: kunshan002
• Status: Completed
• Phase: Phase 4
• Start date: February 2014
• Est. completion date: June 2014

Study information

• Verified date: February 2020
• Source: Kunshan First People's Hospital Affiliated to Jiangsu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Hours

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition

Intervention

Other:
• standard PN
Group 1: a control group who received standard PN

Drug:
• Vifor
iron sucrose, 200 µg/kg per day, was given everyday with PN,
• 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

Locations

Country	Name	City	State
China	Kunshan First Hospital	Kunshan, ,	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Kunshan First People's Hospital Affiliated to Jiangsu University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Hematological evaluation	Hematological evaluation including RBC, Hb, MCV, MCH, MCHC, RET, CRP were measured before and after the intervention. The three groups were all peripheral blood.	up to 2 weeks
Secondary	Iron storage	Iron storage evaluation including ferritin, serum iron, TIBC on the days were measured before and after the intervention.	up to 2 weeks