Premature Birth Clinical Trial
Official title:
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.
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.
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