NCT01362504

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 30, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

October 12, 2011

Status Verified

October 1, 2011

Enrollment Period

3 months

First QC Date

May 26, 2011

Last Update Submit

October 7, 2011

Conditions

Sepsis

Keywords

Pro-adrenomedullinNeonatal sepsisPrognosisSepsis markerClinical sepsisProven sepsis

Study Arms (3)

Clinical sepsis

Proven sepsis

Control group

healthy neonates

Eligibility Criteria

Age24 Weeks - 42 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Clinical sepsis and/or proven sepsis.

You may not qualify if:

  • Acute kidney injury
  • Intracranial hemorrhage (Grade III and IV)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zekai Tahir Burak Maternity Teaching Hospital, Neonatology Unit

Ankara, 06600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

SepsisNeonatal Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Zekai Tahir Burak Maternity and Teaching Hospital

Study Record Dates

First Submitted

May 26, 2011

First Posted

May 30, 2011

Study Start

May 1, 2011

Primary Completion

August 1, 2011

Study Completion

September 1, 2011

Last Updated

October 12, 2011

Record last verified: 2011-10

Locations

TU(1)