Effect of Iron-fortified TPN on Preterm Infants Anemia

NCT01813682 | Unknown DMC

• 1 other identifier: eoitopia
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Infants

Keywords

preterm infant; anemia; iron fortified TPN

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• iron status

  baseline and more than ten days

Other Outcomes (1)

• Oxidative stress parameters Oxidative stress parameters Oxidative stress parameters

  baseline and more than ten days

Study Arms (3)

control group

NO INTERVENTION

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.

treatment group1

EXPERIMENTAL

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

treatment group2

EXPERIMENTAL

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

Interventions

treatment group1 OTHER

fe-1 group with TPN of iron supplementation of 200μg/kg/d.

treatment group1

treatment group2 OTHER

fe-2 group with TPN of iron supplementation of 400μg/BW (BW=birth weight)

treatment group2

Eligibility Criteria

• Age: 1 Day - 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• qingya tang: lead

Study Sites (1)

Xinhua Hospital

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

MeSH Terms

Conditions

Premature Birth; Anemia

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• qingya tang, M.D.

  Shanghai jiaotong university affiliated xinhua hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

qingya tang, M.D.

CONTACT

+8613761184818; tangqingya@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: profecer

Study Record Dates

• First Submitted: March 12, 2013
• First Posted: March 19, 2013
• Study Start: September 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: March 21, 2013

Record last verified: 2013-03

Locations

CN (1)