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

NCT02743572 | Completed DMC

• 1 other identifier: XH-16-002
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Premature Birth

Keywords

premature infant; anemia; iron-fortification; parenteral nutrition; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

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

  up to 2 weeks

Secondary Outcomes (1)

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

  up to 1 month

Other Outcomes (1)

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

  up to 1 month

Study Arms (5)

control group

NO INTERVENTION

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

iron sucrose-1

EXPERIMENTAL

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

Other: iron sucrose-1

iron sucrose-2

EXPERIMENTAL

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

Other: iron sucrose-2

iron sucrose-3

EXPERIMENTAL

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

Other: iron sucrose-3

iron sucrose-4

EXPERIMENTAL

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

Other: iron sucrose-4

Interventions

iron sucrose-1 OTHER

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

iron sucrose-1

iron sucrose-2 OTHER

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

iron sucrose-2

iron sucrose-3 OTHER

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

iron sucrose-3

iron sucrose-4 OTHER

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

iron sucrose-4

Eligibility Criteria

• Age: 1 Hour - 48 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants with birth weight less than 2kg
• Have parenteral nutrition indication
• With written informed consent of parents or guardian

You may not qualify if:

• 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

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua Hospital

Shanghai, Shanghai Municipality, 200092, China

Location

Related 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.

  PMID: 23400604 RESULT

• 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.

  PMID: 24431594 RESULT

• 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.

  PMID: 9386655 RESULT

• 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.

  PMID: 9007491 RESULT

• 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.

  PMID: 23007736 RESULT

• 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.

  PMID: 23641637 RESULT

• 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.

  PMID: 23832487 RESULT

• 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.

  PMID: 22564959 RESULT

MeSH Terms

Conditions

Premature Birth; Anemia; Hyperphagia

Condition Hierarchy (Ancestors)

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

Study Officials

• qingya tang

  Shanghai jiaotong university affiliated xinhua hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: April 19, 2016
• Study Start: September 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: March 7, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)