NCT03310840

Brief Summary

Abstract Background: Neonatal ventilator associated pneumonia (VAP) is a major hospital-acquired infection in acute care settings, associated with high mortality and poor outcome. VAP is considered a preventable infection if the risk factors are managed effectively. The purpose of this study is to evaluate prevalence of ventilator associated pneumonia, its causative organisms, its risk factors and outcome at our NICU. This study used CDC guidelines for infant's ≤1 year old to diagnose neonatal VAP, in period from April 2018 to March 2019.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 16, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

December 23, 2020

Status Verified

December 1, 2020

Enrollment Period

12 months

First QC Date

September 25, 2017

Last Update Submit

December 21, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • mechanical ventilation accused to be risk factor for nosocomial infection in neonate .

    to determine incidence and prevalence of neonatal sepsis on mechanically ventilated neonate

    from april 2018 to march 2019

Secondary Outcomes (1)

  • value of Surveillance program

    from april 2018 to march 2018

Interventions

othersOTHER

others

Eligibility Criteria

Age3 Days - 2 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

porotocal of thesis ;

You may qualify if:

  • Characteristics: all cases All neonate admitted NICU of assiut University Children Hospital , who required endotracheal intubation and mechanical ventilation, regardless neonatal age.
  • Target population, in details : all cases which develop neonatal sepsis on mechanically ventilate neonate admitted in NICU.of assiut university children hospital during the period from January 2018 to December 2018.

You may not qualify if:

  • meconium aspirated pneumonia .
  • Neonates ventilated for infectious

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit University NICU of Children Hospital

Asyut, Egypt

Location

MeSH Terms

Conditions

Neonatal Sepsis

Interventions

Bro protein, Drosophila

Condition Hierarchy (Ancestors)

SepsisInfectionsInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.B.B.CH resident doctor. principal investigator

Study Record Dates

First Submitted

September 25, 2017

First Posted

October 16, 2017

Study Start

April 1, 2018

Primary Completion

March 30, 2019

Study Completion

October 1, 2019

Last Updated

December 23, 2020

Record last verified: 2020-12

Locations