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

NCT02743572 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2018-03-07

No results posted yet for this study

Summary

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.

Conditions

  • Premature Birth

Interventions

OTHER

iron sucrose-1

iron sucrose-1 group with PN of iron supplementation of 100μg/kg/d

OTHER

iron sucrose-2

iron sucrose-2 group with PN of iron supplementation of 200μg/kg/d

OTHER

iron sucrose-3

iron sucrose-3 group with PN of iron supplementation of 300μg/kg/d

OTHER

iron sucrose-4

iron sucrose-4 group with PN of iron supplementation of 400μg/kg/d

Sponsors & Collaborators

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • qingya tang · Shanghai jiaotong university affiliated xinhua hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
1 Hour
Max Age
48 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02743572 on ClinicalTrials.gov