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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02743572
Enrollment
129
Registered
2016-04-19
Start date
2015-09-30
Completion date
2017-05-31
Last updated
2018-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Birth

Keywords

premature infant, anemia, iron-fortification, parenteral nutrition, randomized controlled trial

Brief 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.

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.

Interventions

OTHERiron sucrose-1

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

OTHERiron sucrose-2

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

OTHERiron sucrose-3

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

OTHERiron sucrose-4

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

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
1 Hours to 48 Hours
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Changes of iron status index before and after iron-fortified parenteral nutrition supportup to 2 weeks

Secondary

MeasureTime frame
Changes of iron storage index before and after iron-fortified parenteral nutrition supportup to 1 month

Other

MeasureTime frame
Changes of oxidative stress index before and after iron-fortified parenteral nutrition supportup to 1 month

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026