Iron-fortified Parenteral Nutrition in the Prevention and Treatment of Anemia in Premature Infants
Condition: Premature Birth
MeSH terms: Premature Birth; Anemia
Study type: Interventional

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.
    

Intervention name(s): iron sucrose-1; iron sucrose-2; iron sucrose-3; iron sucrose-4
Intervention type(s): Other; Other; Other; Other
Intervention description(s): iron sucrose-1 group with PN of iron supplementation of 100μg/kg/d; iron sucrose-2 group with PN of iron supplementation of 200μg/kg/d; iron sucrose-3 group with PN of iron supplementation of 300μg/kg/d; iron sucrose-4 group with PN of iron supplementation of 400μg/kg/d
Intervention MeSH terms: Iron; Ferric Oxide, Saccharated
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: premature infant; anemia; iron-fortification; parenteral nutrition; randomized controlled trial