CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 129 enrolled
Drug / intervention
iron sucrose-1 +3 moreother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02743572
NCT02743572N/ACompleted

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

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine·interventional·Posted Apr 19, 2016·Updated Mar 7, 2018

In Brief

A clinical study evaluating iron sucrose-1, iron sucrose-2, and 2 other interventions for Premature Birth. Completed, enrolled 129 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPremature Birth
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 19, 2016
Enrollment StartSep 1, 2015
Primary CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 10.2 years ago

Interventions

iron sucrose-1other

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

iron sucrose-2other

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

iron sucrose-3other

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

iron sucrose-4other

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