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Hepcidin Levels in Preterm Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01539356
First Posted: February 27, 2012
Last Update Posted: March 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Meir Medical Center
  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:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Increase in Hepcidin levels by 30% [ Time Frame: within 24-72 h ]

Enrollment: 62
Study Start Date: March 2012
Study Completion Date: August 2013
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

Information from the National Library of Medicine

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Ages Eligible for Study:   24 Weeks to 37 Weeks   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01539356


Locations
Israel
Neonatal Intensive Care Unit
Kfar-Saba, Israel, 44281
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
First Submitted: February 21, 2012
First Posted: February 27, 2012
Last Update Posted: March 16, 2016
Last Verified: November 2012

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

Additional relevant MeSH terms:
Premature Birth
Sepsis
Neonatal Sepsis
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Infant, Newborn, Diseases
Hepcidins
Anti-Infective Agents