- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01539356
Hepcidin Levels in Preterm Infants
March 15, 2016 updated by: Meir Medical Center
Hepcidin Levels in Preterm Infants Receiving Blood Transfusion and During Sepsis.
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
62
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Kfar-Saba, Israel, 44281
- Neonatal intensive care unit
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 months to 8 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
Inclusion Criteria:
- Preterm < 38 weeks gestation
- Need of blood test for anemia or suspected sepsis
Exclusion Criteria:
- Major congenital anomalies
- Birth Asphyxia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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preterm infants
preterm infants receiving blood transfusion preterm infants with neonatal sepsis. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Increase in Hepcidin levels by 30%
Time Frame: within 24-72 h
|
within 24-72 h
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Yapakci E, Tarcan A, Celik B, Ozbek N, Gurakan 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.
- Muller 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Actual)
February 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
February 21, 2012
First Submitted That Met QC Criteria
February 24, 2012
First Posted (Estimate)
February 27, 2012
Study Record Updates
Last Update Posted (Estimate)
March 16, 2016
Last Update Submitted That Met QC Criteria
March 15, 2016
Last Verified
November 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0154-11-MMC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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