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Effect of Iron-fortified TPN on Preterm Infants Anemia

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ClinicalTrials.gov Identifier: NCT01813682
Recruitment Status : Unknown
Verified March 2013 by qingya tang, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
First Posted : March 19, 2013
Last Update Posted : March 21, 2013
Sponsor:
Information provided by (Responsible Party):
qingya tang, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.


Condition or disease Intervention/treatment Phase
Preterm Infants Other: treatment group1 Other: treatment group2 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Iron-fortified TPN on Preterm Infants Anemia
Study Start Date : September 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

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)




Primary Outcome Measures :
  1. anemia rate [ Time Frame: up to 2 weaks ]
    compare the anemia rate of three groups and identify the effect of iron-fortified TPN for preterm infants.


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


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



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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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): NCT01813682


Contacts
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Contact: qingya tang, M.D. +8613761184818 tangqingya@163.com

Locations
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China, Shanghai
Xinhua Hospital Recruiting
Shanghai, Shanghai, China, 200092
Contact: yexuan tao, PH.D.    +8613818334664    taoyexuan@hotmail.com   
Sponsors and Collaborators
qingya tang
Investigators
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Principal Investigator: qingya tang, M.D. Shanghai jiaotong university affiliated xinhua hospital

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Responsible Party: qingya tang, profecer, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01813682     History of Changes
Other Study ID Numbers: eoitopia
First Posted: March 19, 2013    Key Record Dates
Last Update Posted: March 21, 2013
Last Verified: March 2013

Keywords provided by qingya tang, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:
preterm infant
anemia
iron fortified TPN

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Anemia
Hematologic Diseases
Obstetric Labor Complications
Pregnancy Complications
Iron
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs