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Hepcidin Levels in Preterm Infants

This study is currently recruiting participants.
Verified November 2012 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01539356
First received: February 21, 2012
Last updated: January 28, 2013
Last verified: November 2012
History of Changes
  Purpose

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.


Condition
Preterm Infants
Anemia of Prematurity
Neonatal Sepsis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Hepcidin Levels in Preterm Infants Receiving Blood Transfusion and During Sepsis.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Increase in Hepcidin levels by 30% [ Time Frame: within 24-72 h ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
preterm infants

preterm infants receiving blood transfusion

preterm infants with neonatal sepsis.

  Eligibility

Ages Eligible for Study:   24 Weeks to 37 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Preterm < 38 weeks gestation Need of blood transfusion according to local Protocol. or signs and symptoms of sepsis

Criteria

Inclusion Criteria:

  • Preterm < 38 weeks gestation
  • Need of blood test for anemia or suspected sepsis

Exclusion Criteria:

  • Major congenital anomalies
  • Birth Asphyxia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01539356

Contacts
Contact: Shmuel Arnon, MD 972-9-7472225 shmuelar@clalit.oeg.il

Locations
Israel
Neonatal Intensive Care Unit Recruiting
Kfar-Saba, Israel, 44281
Contact: shmuel arnon, MD         shmuelar@clalit.oeg.il    
Sponsors and Collaborators
Meir Medical Center
  More Information

Publications:

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01539356     History of Changes
Other Study ID Numbers: 0154-11-MMC
Study First Received: February 21, 2012
Last Updated: January 28, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Meir Medical Center:
Hepcidin
Preterm Infants
Anemia
Sepsis
Ferritin

Additional relevant MeSH terms:
Infant, Premature, Diseases
Anemia
Sepsis
Toxemia
Anemia, Neonatal
Hematologic Diseases
Infection
Systemic Inflammatory Response Syndrome
 Inflammation
Pathologic Processes
Infant, Newborn, Diseases
Hepcidin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013