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Effect of Iron-fortified TPN on Preterm Infants Anemia

Primary Purpose

Preterm Infants

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
treatment group1
treatment group2
Sponsored by
qingya tang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Infants focused on measuring preterm infant, anemia, iron fortified TPN

Eligibility Criteria

1 Day - 3 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Xinhua HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

control group

treatment group1

treatment group2

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

anemia rate
compare the anemia rate of three groups and identify the effect of iron-fortified TPN for preterm infants.

Secondary Outcome Measures

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.

Full Information

First Posted
March 12, 2013
Last Updated
March 20, 2013
Sponsor
qingya tang
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1. Study Identification

Unique Protocol Identification Number
NCT01813682
Brief Title
Effect of Iron-fortified TPN on Preterm Infants Anemia
Official Title
Effect of Iron-fortified TPN on Preterm Infants Anemia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
qingya tang

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infants
Keywords
preterm infant, anemia, iron fortified TPN

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
118 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
treatment group1
Arm Type
Experimental
Arm Description
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.
Arm Title
treatment group2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
treatment group1
Intervention Description
fe-1 group with TPN of iron supplementation of 200μg/kg/d.
Intervention Type
Other
Intervention Name(s)
treatment group2
Intervention Description
fe-2 group with TPN of iron supplementation of 400μg/BW (BW=birth weight)
Primary Outcome Measure Information:
Title
anemia rate
Description
compare the anemia rate of three groups and identify the effect of iron-fortified TPN for preterm infants.
Time Frame
up to 2 weaks
Secondary Outcome Measure Information:
Title
iron status
Description
Serum iron, iron protein and total iron binding force are parameters used to test the effectiveness of iron-fortified TPN used for preterm infants.
Time Frame
baseline and more than ten days
Other Pre-specified Outcome Measures:
Title
Oxidative stress parameters Oxidative stress parameters Oxidative stress parameters
Description
we use MDA、 8-iso-prostaglandin F2α as the oxidative stress parameters to identify the safety of iron-fortified TPN used in preterm infants.
Time Frame
baseline and more than ten days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
qingya tang, M.D.
Phone
+8613761184818
Email
tangqingya@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
qingya tang, M.D.
Organizational Affiliation
Shanghai jiaotong university affiliated xinhua hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xinhua Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yexuan tao, PH.D.
Phone
+8613818334664
Email
taoyexuan@hotmail.com

12. IPD Sharing Statement

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Effect of Iron-fortified TPN on Preterm Infants Anemia

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