SepsisNCT01362504
Pro-adrenomedullin as a Prognostic Marker in Neonatal Sepsis
An observational study of Sepsis, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 24 to 42 weeksHealthy volunteers can take part
- Conditions the study is for
- Sepsis
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2011to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 42 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Preterm and term neonates with sepsis were enrolled in this study including 80 cases.
Who may be able to join
- Clinical sepsis and/or proven sepsis.
Who cannot join
- Acute kidney injury
- Intracranial hemorrhage (Grade III and IV)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zekai Tahir Burak Maternity Teaching Hospital, Neonatology Unit
Ankara, 06600
About this study
Official title: 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.
- Conditions
- Sepsis
- Keywords
- Pro-adrenomedullin, Neonatal sepsis, Prognosis, Sepsis marker, Clinical sepsis, Proven sepsis
- Medical subject headings
- Sepsis, Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Clinical sepsis | Not described | |
| Proven sepsis | Not described | |
| Control group | healthy neonates |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2011 (estimated)
- Study startMay 2011
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Yekta, Zekai Tahir Burak Women's Health Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362504
- Sponsor's protocol ID
- ZTB0663
- Status last verified
- Oct 2011
- First submitted
- 26 May 2011
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zekai Tahir Burak Maternity Teaching Hospital Neonatal Intensive Care Unit
- ClinicalTrials.gov ID
- NCT01362504
- Acronym / sponsor ID
- ZTB0663
- Conditions
- Sepsis
- Keywords
- Pro-adrenomedullin, Neonatal sepsis, Prognosis, Sepsis marker, Clinical sepsis, Proven sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 30 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clinical sepsis | – | – |
| Proven sepsis | – | – |
| Control group | – | –healthy neonates |
Who may qualify
- Ages
- 24 to 42 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Preterm and term neonates with sepsis were enrolled in this study including 80 cases.
Key inclusion criteria (1 listed)
- Clinical sepsis and/or proven sepsis.
Key exclusion criteria (2 listed)
- Acute kidney injury
- Intracranial hemorrhage (Grade III and IV)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2011; AzTrials last refreshed its copy on 7 Nov 2026.