- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01362504
Pro-adrenomedullin as a Prognostic Marker in Neonatal Sepsis
October 7, 2011 updated by: Mehmet Yekta, Zekai Tahir Burak Women's Health Research and Education Hospital
Zekai Tahir Burak Maternity Teaching Hospital Neonatal Intensive Care Unit
The aim of this study was to clarify the prognostic value of serum pro-Adrenomedullin level in neonatal sepsis.
Eighty term and preterm neonates with sepsis were enrolled in this study.
Eighty healthy matched neonates served as a control group.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
80
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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Ankara, Turkey, 06600
- Zekai Tahir Burak Maternity Teaching Hospital, Neonatology 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 9 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Preterm and term neonates with sepsis were enrolled in this study including 80 cases.
Description
Inclusion Criteria:
- Clinical sepsis and/or proven sepsis.
Exclusion Criteria:
- Acute kidney injury
- Intracranial hemorrhage (Grade III and IV)
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
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Clinical sepsis
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Proven sepsis
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Control group
healthy neonates
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
May 1, 2011
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
May 26, 2011
First Submitted That Met QC Criteria
May 27, 2011
First Posted (Estimate)
May 30, 2011
Study Record Updates
Last Update Posted (Estimate)
October 12, 2011
Last Update Submitted That Met QC Criteria
October 7, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZTB0663
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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