Effect of Iron-fortified TPN on Preterm Infants Anemia

The purpose of this study is to determine whether iron-fortified TPN is effective in the preventative and treatment of preterm infants. Preterm infants are at risk for anemia especially in preterm infants. Generally the smaller Birth weight and gestational age the higher anemia rate in infants. About 25% to 85% of preterm infants develop evidence of anemia during infancy，77% VLBW（very low birth weight） infants developed anemia during the hospital stay. The effects of iron deficiency are pervasive and involve multiple organ systems. Poor physical growth, gastrointestinal disturbances, thyroid dysfunction, altered immunity and temperature instability has been attributed to iron deficiency in very low birth weight infants. So it is important to provide iron for preterm infants.

As enteral nutrition is not feasible soon after birth in most preterm infants, Parenteral iron administration is an efficacious method for us to select. For most preterm infants the use of TPN(total parenteral nutrition) is very common during the first ten days of life, so we hypothesis that iron-fortified TPN may have a preventative and treatment effect on preterm infants using TPN as a supplementation of oral nutrition; Iron-fortified TPN(total parenteral nutrition) can also improve iron store status of preterm infants. The higher concentration of iron used in this study the larger preventative or treatment effect on preterm infants anemia; It is safe to add Small dose of iron agent to TPN.

Study Overview

• Status: Unknown
• Conditions: Preterm Infants
• Intervention / Treatment: Other: treatment group1; Other: treatment group2

Detailed Description

Preterm infants are at high risk of anemia especially low birth weight infants, so it is important to supply iron with infants of this group.

90 preterm infants BW(birth weight) less than 2kg,entered neonatal intensive care unit(NICU) less than 72 hours and meet the Inclusion Criteria of this study will be Randomly divided into three groups, control group、 treatment group1 (200μg/kg/d,and the highest concentration of iron is ≤0.8g/100ml TPN)、treatment group2 （400μg/kg/d,and the highest concentration of iron is ≤0.8g/100ml TPN）. iron supplementation period for more than ten days. For three groups, complete blood counts, differential counts, and reticulocyte counts were measured weekly in samples obtained, serum iron, iron protein, total iron binding force were measured at baseline and after 2 weeks. Through comparative analysis of three groups, to find iron-fortified TPN whether affect anemia rate and iron storage in preterm. we also selected malondialdehyde (MDA)and 8-iso-prostaglandin F2α(8-iso-PGF2α) as our concerns about iron used in TPN induces oxidative stress index.

Iron protein determination use radioimmunoassay method, serum iron and total iron binding force determination use chemical method, MDA and 8-iso-PGF2α determination use enzyme-linked immunosorbent assay method.

• Study Type: Interventional
• Enrollment (Anticipated): 118
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: qingya tang, M.D.; Phone Number: +8613761184818; Email: tangqingya@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200092
      • Recruiting
      • Xinhua Hospital
      • Contact: yexuan tao, PH.D.; Phone Number: +8613818334664; Email: taoyexuan@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Preterm infants with birth weight less than 2kg Have parenteral nutrition indication With written informed consent of parents or guardian

Exclusion Criteria:

• have already used TPN before randomization 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; preterm infants of this group with iron-free TPN for more than ten days, compare serum iron, iron protein, total iron binding force, MDA, 8-iso-PGF2α on baseline and after intervention.
Experimental: treatment group1; preterm infants of this group with iron supplementation of 200μg/kg/d for more than ten days, compare serum iron, iron protein, total iron binding force, MDA, 8-iso-PGF2α on baseline and after intervention.	Other: treatment group1; fe-1 group with TPN of iron supplementation of 200μg/kg/d.
Experimental: treatment group2; preterm infants of this group with iron supplementation of 400μg/kg/d for more than ten days, compare serum iron, iron protein, total iron binding force, MDA, 8-iso-PGF2α on baseline and after intervention.	Other: treatment group2; fe-2 group with TPN of iron supplementation of 400μg/BW (BW=birth weight)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anemia rate	compare the anemia rate of three groups and identify the effect of iron-fortified TPN for preterm infants.	up to 2 weaks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
iron status	Serum iron, iron protein and total iron binding force are parameters used to test the effectiveness of iron-fortified TPN used for preterm infants.	baseline and more than ten days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxidative stress parameters Oxidative stress parameters Oxidative stress parameters	we use MDA、 8-iso-prostaglandin F2α as the oxidative stress parameters to identify the safety of iron-fortified TPN used in preterm infants.	baseline and more than ten days

Collaborators and Investigators

• Sponsor: qingya tang
• Investigators: Principal Investigator: qingya tang, M.D., Shanghai jiaotong university affiliated xinhua hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): June 1, 2014

Study Registration Dates

• First Submitted: March 12, 2013
• First Submitted That Met QC Criteria: March 14, 2013
• First Posted (Estimate): March 19, 2013

Study Record Updates

• Last Update Posted (Estimate): March 21, 2013
• Last Update Submitted That Met QC Criteria: March 20, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: anemia; preterm infant; iron fortified TPN
• Additional Relevant MeSH Terms: Hematologic Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Anemia
• Other Study ID Numbers: eoitopia