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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02743572
• Other study ID #: XH-16-002
• Status: Completed
• Phase: N/A
• First received: March 31, 2016
• Last updated: March 6, 2018
• Start date: September 2015
• Est. completion date: May 2017

Study information

• Verified date: March 2018
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 48 Hours

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Premature Birth

Intervention

Other:
• iron sucrose-1
iron sucrose-1 group with PN of iron supplementation of 100µg/kg/d
• iron sucrose-2
iron sucrose-2 group with PN of iron supplementation of 200µg/kg/d
• iron sucrose-3
iron sucrose-3 group with PN of iron supplementation of 300µg/kg/d
• iron sucrose-4
iron sucrose-4 group with PN of iron supplementation of 400µg/kg/d

Locations

Country	Name	City	State
China	Xinhua Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (8)

Chang S, Zeng L, Brouwer ID, Kok FJ, Yan H. Effect of iron deficiency anemia in pregnancy on child mental development in rural China. Pediatrics. 2013 Mar;131(3):e755-63. doi: 10.1542/peds.2011-3513. Epub 2013 Feb 11. — View Citation

Cooke RW, Drury JA, Yoxall CW, James C. Blood transfusion and chronic lung disease in preterm infants. Eur J Pediatr. 1997 Jan;156(1):47-50. — View Citation

Heming N, Lettéron P, Driss F, Millot S, El Benna J, Tourret J, Denamur E, Montravers P, Beaumont C, Lasocki S. Efficacy and toxicity of intravenous iron in a mouse model of critical care anemia*. Crit Care Med. 2012 Jul;40(7):2141-8. doi: 10.1097/CCM.0b0 — View Citation

Inder TE, Clemett RS, Austin NC, Graham P, Darlow BA. High iron status in very low birth weight infants is associated with an increased risk of retinopathy of prematurity. J Pediatr. 1997 Oct;131(4):541-4. — View Citation

Moshtaghie M, Malekpouri P, Dinko MR, Moshtaghie AA. Changes in serum parameters associated with iron metabolism in male rat exposed to lead. J Physiol Biochem. 2013 Jun;69(2):297-304. doi: 10.1007/s13105-012-0212-9. Epub 2012 Sep 25. — View Citation

Plummer ES, Crary SE, McCavit TL, Buchanan GR. Intravenous low molecular weight iron dextran in children with iron deficiency anemia unresponsive to oral iron. Pediatr Blood Cancer. 2013 Nov;60(11):1747-52. doi: 10.1002/pbc.24676. Epub 2013 Jul 6. — View Citation

Singh S, Singh S, Singh PK. A study to compare the efficacy and safety of intravenous iron sucrose and intramuscular iron sorbitol therapy for anemia during pregnancy. J Obstet Gynaecol India. 2013 Mar;63(1):18-21. doi: 10.1007/s13224-012-0248-3. Epub 201 — View Citation

Smith S. Safe administration of intravenous iron therapy. Nurs Stand. 2013 Apr 3-9;27(31):45-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes of oxidative stress index before and after iron-fortified parenteral nutrition support		up to 1 month
Primary	Changes of iron status index before and after iron-fortified parenteral nutrition support		up to 2 weeks
Secondary	Changes of iron storage index before and after iron-fortified parenteral nutrition support		up to 1 month