Pro-adrenomedullin as a Prognostic Marker in Neonatal Sepsis | NCT01362504

Studies
Pro-adrenomedullin as a Prognostic Marker in Neonatal Sepsis

NCT01362504

Sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Status

Completed

Last Update Posted

Oct 12, 2011Estimated

Enrollment

80Estimated

Phase

Not provided

Conditions

Sepsis

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Aug 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

May 26, 2011

First Submission Date that Met QC Criteria

May 27, 2011

First Posted Date

May 30, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2011

Last Update Posted Date

Oct 12, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mehmet Yekta, Zekai Tahir Burak Maternity and Teaching Hospital, Zekai Tahir Burak Women's Health Research and Education HospitalPrincipal Investigator

Lead Sponsor

Zekai Tahir Burak Women's Health Research and Education HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical sepsis and/or proven sepsis.

Exclusion Criteria:

Acute kidney injury
Intracranial hemorrhage (Grade III and IV)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

24 Weeks

Maximum Age

42 Weeks

Standard Ages

Child

Study Population

Preterm and term neonates with sepsis were enrolled in this study including 80 cases.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zekai Tahir Burak Maternity Teaching Hospital, Neonatology Unit		Ankara		06600	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis
D000071074	Neonatal Sepsis

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Clinical sepsis
Proven sepsis
Control group		healthy neonates