<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03254316</url>
  </required_header>
  <id_info>
    <org_study_id>HCAISN</org_study_id>
    <nct_id>NCT03254316</nct_id>
  </id_info>
  <brief_title>Health Care Associated Infection Surveillance in NICU</brief_title>
  <official_title>Healthcare Associated Infection Surveillance in NICU of Assiut University Children's Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gehad Salah El-Den Mahmoud Mohammad</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Healthcare - Associated Infection Surveillance In Neonatal Intensive Care Unit of Assiut&#xD;
      University Children's Hospital.The objective of study is to determine the incidence,&#xD;
      infection sites, causative organisms and risk factors related to healthcare-associated&#xD;
      infections in NICU in Assiut University Children hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nosocomial infections (NIs) are a major public health problem worldwide . Nosocomial&#xD;
      infections are those acquired in or associated with hospitals. They are also known as&#xD;
      hospital-acquired or healthcare-associated infections. The usual deﬁnition of a&#xD;
      hospital-acquired infection is one that was not present or incubating when the patient was&#xD;
      admitted to a hospital or healthcare facility; where there is doubt, a cut-off period of 48&#xD;
      hours after admission is used.The terms hospital-acquired and healthcare-associated are often&#xD;
      used interchangeably, but 'healthcare-associated' also has the wider meaning of any infection&#xD;
      acquired as a result of healthcare in any setting.&#xD;
&#xD;
      Nosocomial infections are common, and may be serious or fatal. Some are unavoidable but&#xD;
      doctors' duty of care to their patients extends to fundamental matters such as basic hygiene,&#xD;
      which may prevent patients becoming infected, and avoidance of unnecessary antibiotics, to&#xD;
      discourage development of resistance Health care-associated infections (HC-AIs) are a major&#xD;
      cause of morbidity and mortality in neonatal intensive care units (NICUs) and lead to&#xD;
      increases in hospital length of stay and treatment cost. Higher nosocomial infection&#xD;
      incidence in NICUs was related to longer duration of hospital stay, and invasive&#xD;
      interventions and medical treatments. HC-AIs, especially device-associated health&#xD;
      care-associated infections (DA-HAIs), were also common in newborns because of their&#xD;
      insufﬁcient immune system and mechanical barriers, as well as lack of protective ﬂora&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Actual">October 1, 2019</completion_date>
  <primary_completion_date type="Actual">October 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Detect incidence of nosocomial infection in NICU</measure>
    <time_frame>1 year</time_frame>
    <description>To detect impact of nosocomial infection on outcome of neonates admitted in NICU</description>
  </primary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Health Care Associated Infection</condition>
  <eligibility>
    <study_pop>
      <textblock>
        This is a prospective clinical study covered a period of 12 months in a tertiary neonatal&#xD;
        intensive care unit in NICU of Assiut university children's hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age at admission ( 0-28 DAY )&#xD;
&#xD;
          2. Neonates who admitted for more than 48 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age:more than 28days&#xD;
&#xD;
          2. Neonates who admitted for less than 48 hours.&#xD;
&#xD;
          3. Neonates who admitted for infection reasons as (pneumonia, MAS, AGE and skin&#xD;
             infection).&#xD;
&#xD;
          4. Neonates with potentially infection (PROM, chorioamnionitis, TOF)&#xD;
&#xD;
          5. Neonates with congenital infections&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>28 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Asmaa Shorat, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assiut university hospital</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>January 1, 2020</last_update_submitted>
  <last_update_submitted_qc>January 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Gehad Salah El-Den Mahmoud Mohammad</investigator_full_name>
    <investigator_title>Resident doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Cross Infection</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03254316
org study id: HCAISN
nct id: NCT03254316
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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
observational model: Cohort
time perspective: Prospective
measure: Detect incidence of nosocomial infection in NICU
time frame: 1 year
description: To detect impact of nosocomial infection on outcome of neonates admitted in NICU
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 28 Days
healthy volunteers: No
last name: Asmaa Shorat, Professor
role: Study Director
affiliation: Assiut University
facility: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Assiut University
investigator full name: Gehad Salah El-Den Mahmoud Mohammad
investigator title: Resident doctor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Cross Infection