Hepcidin Levels in Preterm Infants

Neonatal Sepsis Clinical Trial

Official title:

Hepcidin Levels in Preterm Infants Receiving Blood Transfusion and During Sepsis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01539356
• Other study ID #: 0154-11-MMC
• Status: Completed
• Phase: N/A
• First received: February 21, 2012
• Last updated: March 15, 2016
• Start date: March 2012
• Est. completion date: August 2013

Study information

• Verified date: November 2012
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

A recently isolated peptide hormone, hepcidin, is thought to be the principal regulator of iron homeostasis. Hepcidin acts by limiting intestinal iron absorption and promoting iron retention in reticuloendothelial cells. The aims of this study were to determine serum hepcidin levels in preterm infants who receive blood transfusion and preterm infants having sepsis, in order to assess possible relationships between hepcidin and serum iron, serum ferritin,in iron load situations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Weeks to 37 Weeks

Eligibility

Inclusion Criteria:

• Preterm < 38 weeks gestation

• Need of blood test for anemia or suspected sepsis

Exclusion Criteria:

• Major congenital anomalies

• Birth Asphyxia

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia of Prematurity
• Anemia, Neonatal
• Infant, Premature, Diseases
• Neonatal Sepsis
• Premature Birth
• Preterm Infants
• Sepsis

Locations

Country	Name	City	State
Israel	Neonatal Intensive Care Unit	Kfar-Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (2)

Müller KF, Lorenz L, Poets CF, Westerman M, Franz AR. Hepcidin concentrations in serum and urine correlate with iron homeostasis in preterm infants. J Pediatr. 2012 Jun;160(6):949-53.e2. doi: 10.1016/j.jpeds.2011.12.030. Epub 2012 Jan 28. Erratum in: J Pediatr. 2015 Sep;167(3):782. — View Citation

Yapakçi E, Tarcan A, Celik B, Ozbek N, Gürakan B. Serum pro-hepcidin levels in term and preterm newborns with sepsis. Pediatr Int. 2009 Apr;51(2):289-92. doi: 10.1111/j.1442-200X.2008.02688.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in Hepcidin levels by 30%		within 24-72 h	No