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Hepcidin Levels in Preterm Infants

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ClinicalTrials.gov Identifier: NCT01539356
Recruitment Status : Completed
First Posted : February 27, 2012
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

Tracking Information
First Submitted Date February 21, 2012
First Posted Date February 27, 2012
Last Update Posted Date March 16, 2016
Study Start Date March 2012
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 24, 2012)
Increase in Hepcidin levels by 30% [ Time Frame: within 24-72 h ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01539356 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Hepcidin Levels in Preterm Infants
Official Title Hepcidin Levels in Preterm Infants Receiving Blood Transfusion and During Sepsis.
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Preterm Infants
  • Anemia of Prematurity
  • Neonatal Sepsis
Intervention Not Provided
Study Groups/Cohorts preterm infants

preterm infants receiving blood transfusion

preterm infants with neonatal sepsis.

Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 15, 2016)
62
Original Estimated Enrollment
 (submitted: February 24, 2012)
50
Actual Study Completion Date August 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Major congenital anomalies
  • Birth Asphyxia
Sex/Gender
Sexes Eligible for Study: All
Ages 24 Weeks to 37 Weeks   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT01539356
Other Study ID Numbers 0154-11-MMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Meir Medical Center
Study Sponsor Meir Medical Center
Collaborators Not Provided
Investigators Not Provided
PRS Account Meir Medical Center
Verification Date November 2012