Iron-fortified Parenteral Nutrition in the Prevention and Treatment of Anemia in Premature Infants
NCT ID: NCT02743572
Last Updated: 2018-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
129 participants
INTERVENTIONAL
2015-09-30
2017-05-31
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
TRIPLE
Study Groups
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control group
preterm infants of this group with iron-free PN for more than seven days, compare erythrocyte parameters, serum iron, iron protein and MDA on baseline and after intervention
No interventions assigned to this group
iron sucrose-1
preterm infants of this group with iron supplementation of 100μg/kg/d for more than seven days, compare erythrocyte parameters, serum iron, iron protein and MDA on baseline and after intervention
iron sucrose-1
iron sucrose-1 group with PN of iron supplementation of 100μg/kg/d
iron sucrose-2
preterm infants of this group with iron supplementation of 200μg/kg/d for more than seven days, compare erythrocyte parameters, serum iron, iron protein and MDA on baseline and after intervention
iron sucrose-2
iron sucrose-2 group with PN of iron supplementation of 200μg/kg/d
iron sucrose-3
preterm infants of this group with iron supplementation of 300μg/kg/d for more than seven days, compare erythrocyte parameters, serum iron, iron protein and MDA on baseline and after intervention
iron sucrose-3
iron sucrose-3 group with PN of iron supplementation of 300μg/kg/d
iron sucrose-4
preterm infants of this group with iron supplementation of 400μg/kg/d for more than seven days, compare erythrocyte parameters, serum iron, iron protein and MDA on baseline and after intervention
iron sucrose-4
iron sucrose-4 group with PN of iron supplementation of 400μg/kg/d
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Have parenteral nutrition indication
* With written informed consent of parents or guardian
Exclusion Criteria
* 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
1 Hour
48 Hours
ALL
No
Sponsors
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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qingya tang
Professor
Principal Investigators
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qingya tang
Role: PRINCIPAL_INVESTIGATOR
Shanghai jiaotong university affiliated xinhua hospital
Locations
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Xinhua Hospital
Shanghai, Shanghai Municipality, China
Countries
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References
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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.
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 2012 Sep 12.
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. doi: 10.1016/s0022-3476(97)70058-1.
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. doi: 10.1007/s004310050551.
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.
Smith S. Safe administration of intravenous iron therapy. Nurs Stand. 2013 Apr 3-9;27(31):45-8. doi: 10.7748/ns2013.04.27.31.45.e5162.
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.
Heming N, Letteron 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.0b013e31824e6713.
Other Identifiers
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XH-16-002
Identifier Type: -
Identifier Source: org_study_id
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