NCT03254316

Brief Summary

Healthcare - Associated Infection Surveillance In Neonatal Intensive Care Unit of Assiut University Children's Hospital.The objective of study is to determine the incidence, infection sites, causative organisms and risk factors related to healthcare-associated infections in NICU in Assiut University Children hospital.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

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

August 16, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

January 3, 2020

Status Verified

January 1, 2020

Enrollment Period

1.8 years

First QC Date

August 16, 2017

Last Update Submit

January 1, 2020

Conditions

Health Care Associated Infection

Outcome Measures

Primary Outcomes (1)

  • Detect incidence of nosocomial infection in NICU

    To detect impact of nosocomial infection on outcome of neonates admitted in NICU

    1 year

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

This is a prospective clinical study covered a period of 12 months in a tertiary neonatal intensive care unit in NICU of Assiut university children's hospital.

You may qualify if:

  • Age at admission ( 0-28 DAY )
  • Neonates who admitted for more than 48 hours

You may not qualify if:

  • Age:more than 28days
  • Neonates who admitted for less than 48 hours.
  • Neonates who admitted for infection reasons as (pneumonia, MAS, AGE and skin infection).
  • Neonates with potentially infection (PROM, chorioamnionitis, TOF)
  • Neonates with congenital infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university hospital

Asyut, Egypt

Location

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Asmaa Shorat, Professor

    Assiut University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

August 16, 2017

First Posted

August 18, 2017

Study Start

December 1, 2017

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

January 3, 2020

Record last verified: 2020-01

Locations

EG(1)