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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03254316
Other study ID # HCAISN
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2017
Est. completion date October 1, 2019

Study information

Verified date January 2020
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Nosocomial infections (NIs) are a major public health problem worldwide . Nosocomial infections are those acquired in or associated with hospitals. They are also known as hospital-acquired or healthcare-associated infections. The usual definition of a hospital-acquired infection is one that was not present or incubating when the patient was admitted to a hospital or healthcare facility; where there is doubt, a cut-off period of 48 hours after admission is used.The terms hospital-acquired and healthcare-associated are often used interchangeably, but 'healthcare-associated' also has the wider meaning of any infection acquired as a result of healthcare in any setting.

Nosocomial infections are common, and may be serious or fatal. Some are unavoidable but doctors' duty of care to their patients extends to fundamental matters such as basic hygiene, which may prevent patients becoming infected, and avoidance of unnecessary antibiotics, to discourage development of resistance Health care-associated infections (HC-AIs) are a major cause of morbidity and mortality in neonatal intensive care units (NICUs) and lead to increases in hospital length of stay and treatment cost. Higher nosocomial infection incidence in NICUs was related to longer duration of hospital stay, and invasive interventions and medical treatments. HC-AIs, especially device-associated health care-associated infections (DA-HAIs), were also common in newborns because of their insufficient immune system and mechanical barriers, as well as lack of protective flora


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date October 1, 2019
Est. primary completion date October 1, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 28 Days
Eligibility Inclusion Criteria:

1. Age at admission ( 0-28 DAY )

2. Neonates who admitted for more than 48 hours

Exclusion Criteria:

1. Age:more than 28days

2. Neonates who admitted for less than 48 hours.

3. Neonates who admitted for infection reasons as (pneumonia, MAS, AGE and skin infection).

4. Neonates with potentially infection (PROM, chorioamnionitis, TOF)

5. Neonates with congenital infections

Study Design


Locations

Country Name City State
Egypt Assiut university hospital Assiut

Sponsors (1)

Lead Sponsor Collaborator
Gehad Salah El-Den Mahmoud Mohammad

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Detect incidence of nosocomial infection in NICU To detect impact of nosocomial infection on outcome of neonates admitted in NICU 1 year
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