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CompletedNCT03254316Updated Jan 3, 2020

Health Care Associated Infection Surveillance in NICU

An observational study in Health Care Associated Infection, sponsored by Gehad Salah El-Den Mahmoud Mohammad. Completed at 1 site in Egypt. Open to participants aged 1 Day to 28 Days. Per ClinicalTrials.gov, last updated 2020-01-03.

Sponsored by Gehad Salah El-Den Mahmoud Mohammad · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
1 Day to 28 Days
Sex
All
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Study 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.

Read the detailed 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

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Conditions studied

  • Health Care Associated Infection

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In context

Cross Infection

285 studies on the registry are indexed under Cross Infection; 48 are open to participants now.

This study's enrollment of 100 is below the median of 351 across 115 observational studies indexed under Cross Infection.

Browse Cross Infection studies →

Lead sponsor

This is the only study on the registry with Gehad Salah El-Den Mahmoud Mohammad as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Day to 28 Days
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Detect incidence of nosocomial infection in NICU

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

    Time frame: 1 year

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Study locations

1 site
  • Assiut university hospital
    Assiut, Egypt
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2017 to primary completion in Oct 2019, 22 months.

Of 56 non-industry observational studies under Cross Infection, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 65. This study's 22 months is below that.

Counting every sponsor, half of 56 studies reached it within 28 months; a quarter within 17 and three quarters within 65.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 16, 2017
First posted
Aug 18, 2017
StartActual
Dec 1, 2017
Primary completionActual
Oct 1, 2019
CompletionActual
Oct 1, 2019
Last update
Jan 3, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03254316
Lead sponsor
Gehad Salah El-Den Mahmoud Mohammad
Responsible party
Gehad Salah El-Den Mahmoud Mohammad (Resident doctor, Assiut University) — Sponsor-investigator
First posted
Aug 18, 2017
Start date
Dec 1, 2017
Primary completion
Oct 1, 2019
Completion
Oct 1, 2019
Last update
Jan 3, 2020

Study contacts

Asmaa Shorat, Professor
study director · Assiut University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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