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NCT Number: NCT02743572

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

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.

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Key information

Conditions

Premature Birth Anemia Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Hyperphagia Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Signs and Symptoms, Digestive Urogenital Diseases

Age range

1 hour–48 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xinhua Hospital

Shanghai, Shanghai Municipality, 200092, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iron sucrose-1

Other

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

iron sucrose-2

Other

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

iron sucrose-3

Other

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

iron sucrose-4

Other

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

Primary outcomes

  1. Changes of iron status index before and after iron-fortified parenteral nutrition support

    Time frame: up to 2 weeks

Secondary outcomes

  1. Changes of iron storage index before and after iron-fortified parenteral nutrition support

    Time frame: up to 1 month

Other outcomes

  1. Changes of oxidative stress index before and after iron-fortified parenteral nutrition support

    Time frame: up to 1 month

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 19, 2016
Registry last updated
Mar 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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