Iron-fortified Parenteral Nutrition in the Prevention and Treatment of Anemia in Premature Infants

March 6, 2018 updated by: qingya tang, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Efficacy and Safety of Parenteral Nutrition With Iron Sucrose for Anemia in Preterm Infants: a Randomized, Double-blind Controlled Study

The purpose of this study is to determine whether iron-fortified PN is effective in the preventative and treatment of preterm infants. Preterm infants are at risk for anemia especially in preterm infants. Anemia effects growing development, clinical prognosis, cognition, movement, learning ability and behavioral development.

As enteral nutrition is not feasible soon after birth in most preterm infants, parenteral iron administration is an efficacious method for investigators to select. For most preterm infants, the use of parenteral nutrition(PN) is very common during the first ten days of life, so the investigators hypothesis that iron-fortified PN may have a preventative and treatment effect on preterm infants using PN as a supplementation of oral nutrition; Iron-fortified PN 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 PN.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Infants are at risk for anemia especially in preterm infants. Generally the smaller birth weight and gestational age, the higher anemia ate in infants. As enteral nutrition is not feasible soon after birth in most preterm infants, parenteral iron administration is an efficacious method for investigators to select.

Meeting the Inclusion Criteria of this study will be randomly divided into five groups, control group, group1 (100μg/kg/d, and the highest concentration of iron is ≤0.8g/100ml PN), group2（200μg/kg/d, and the highest concentration of iron is ≤0.8g/100ml PN), group3 (300μg/kg/d, and the highest concentration of iron is ≤0.8g/100ml PN), group4 (400μg/kg/d, and the highest concentration of iron is ≤0.8g/100ml PN). Iron supplementation period for more than ten days. For five 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 five groups, to find iron-fortified PN whether affect anemia rate and iron storage in premature infants. The investigators also selected malondialdehyde (MDA) and 8-isoprostaglandin F2α (8-iso-PGF2α) as the investigators concerns about iron used in PN 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.

The investigators hypothesis that iron-fortified PN may have a preventative and treatment effect on preterm infants using PN as a supplementation of parenteral nutrition; Iron-fortified PN 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.

Study Type

Interventional

Enrollment (Actual)

129

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200092
        • Xinhua Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 hour to 2 days (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 PN before randomization
  • Kidney and liver function abnormal
  • Have hemolytic disease
  • Have hemorrhagic disease
  • Have Serious congenital malformation
  • Have septicemia
  • Have plethora newborn
  • Use PN less than ten days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
preterm infants of this group with iron-free PN for more than seven days, compare erythrocyte parameters, serum iron, iron protein and MDA on baseline and after intervention
Experimental: iron sucrose-1
preterm infants of this group with iron supplementation of 100μg/kg/d for more than seven days, compare erythrocyte parameters, serum iron, iron protein and MDA on baseline and after intervention
Other: iron sucrose-1
iron sucrose-1 group with PN of iron supplementation of 100μg/kg/d
Experimental: iron sucrose-2
preterm infants of this group with iron supplementation of 200μg/kg/d for more than seven days, compare erythrocyte parameters, serum iron, iron protein and MDA on baseline and after intervention
Other: iron sucrose-2
iron sucrose-2 group with PN of iron supplementation of 200μg/kg/d
Experimental: iron sucrose-3
preterm infants of this group with iron supplementation of 300μg/kg/d for more than seven days, compare erythrocyte parameters, serum iron, iron protein and MDA on baseline and after intervention
Other: iron sucrose-3
iron sucrose-3 group with PN of iron supplementation of 300μg/kg/d
Experimental: iron sucrose-4
preterm infants of this group with iron supplementation of 400μg/kg/d for more than seven days, compare erythrocyte parameters, serum iron, iron protein and MDA on baseline and after intervention
Other: iron sucrose-4
iron sucrose-4 group with PN of iron supplementation of 400μg/kg/d

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes of iron status index before and after iron-fortified parenteral nutrition support
Time Frame: up to 2 weeks
up to 2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes of iron storage index before and after iron-fortified parenteral nutrition support
Time Frame: up to 1 month
up to 1 month

Other Outcome Measures

Outcome Measure
Time Frame
Changes of oxidative stress index before and after iron-fortified parenteral nutrition support
Time Frame: up to 1 month
up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: qingya tang, Shanghai jiaotong university affiliated xinhua hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

March 31, 2016

First Submitted That Met QC Criteria

April 14, 2016

First Posted (Estimate)

April 19, 2016

Study Record Updates

Last Update Posted (Actual)

March 7, 2018

Last Update Submitted That Met QC Criteria

March 6, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XH-16-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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