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    Final Cp Proposal 2022 (1)

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    Final Cp Proposal 2022 (1)

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    1 views48 pages

    Final Cp Proposal 2022 (1)

    Uploaded by

    kidlytning.alche

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    of 48

    BACTERIOLOGIC AND CLINICAL PROFILE OF

    NEONATAL SEPSIS IN A TERTIARY HOSPITAL


    IN VALENZUELA CITY: A RETROSPECTIVE
    STUDY
    Principal Investigator: Gian Ysmael B. Tejada M.D
    INTRODUCTION
    • Sepsis is the most common • Remarkable
    cause of neonatal morbidity developments have been
    made in recent years to
    and mortality. reduce the number of
    neonatal deaths globally.
    • Neonatal sepsis is a
    generalized bacterial
    infection documented by a
    positive blood culture in the
    first four weeks of life,
    along with a clinical
    syndrome characterized by
    systemic signs of infection.
    Classifications of neonatal sepsis
    1. Early onset neonatal sepsis – with signs of infection <72
    hours of life. Usually results from organisms acquired
    intrapartum.

    2. Late onset neonatal sepsis- with signs of infection > 72


    hours of life. Usually acquired from the environment.
    NEONATAL SEPSIS
    >There is remarkable
    heterogeneity among studies
    regarding the case definition of
    neonatal sepsis.

    >The “gold standard” in


    diagnosing Neonatal sepsis is
    the presence of a positive blood
    culture.

    >Negative blood and other


    sterile site cultures with
    manifesting signs consistent
    with infection may be
    considered to have “clinical”
    sepsis.
    NEONATAL SEPSIS
    >Evidence of *SIRS in both
    adult and pediatric consensus is
    a prerequisite to meet the
    criteria for sepsis.

    *SIRS requires either 1) abnormal


    WBC count [total WBC increased or
    decreased for age -or- >10%
    immature neutrophils] or 2)
    abnormal core temperature (>38.5°
    or <36°C).
    NEONATAL SEPSIS
    > International data are difficult to standardize in the
    absence of unified criteria for neonatal sepsis. Recently, in adults,
    the Third International Consensus Definitions for Sepsis and Septic
    Shock (Sepsis-3) have defined sepsis as a life-threatening organ
    dysfunction caused by a dysregulated response to infection.

    >The new consensus definition moved away from the concept of


    systemic inflammatory response syndrome, which formed part of
    the definition of sepsis in the past 20 years.

    >The criteria to define infection and sepsis are essential


    in the neonatal population to limit over diagnosis, but they are not
    part of the adult Sepsis-3 definitions.

    > CONCLUSION: There are multiple definitions of


    neonatal sepsis used internationally that encompass clinical,
    microbiological and biochemical data as well as treatment
    initiation and duration.

    >consensus definition is required that can


    be universally generalizable and validated in international datasets.
    BACKGROUND
    In 2013 however, 44% of deaths in children under five
    occurred during the neonatal period (up from 37% in 1990).

    It was found that the three major causes of neonatal deaths


    worldwide were infection from neonatal sepsis/pneumonia
    (36%), pre-term birth (28%), and birth asphyxia (23%).
    BACKGROUND
    Bacterial infections are the primary cause of death in
    term-infants, pneumonia being responsible for 19%, neonatal
    tetanus for 14%, sepsis/meningitis for 7% and diarrhea for 2% of
    the deaths…

    In developing countries, the incidence of neonatal


    sepsis ranges from 7.8 to 21.8/1000 live births, with case fatality
    rates as high as 38%.

    The WHO estimates that > 1 million neonatal deaths worldwide


    annually are caused by severe infections and 1 million deaths are due
    to neonatal sepsis and pneumonia alone.
    • Despite major advances and increasing research in neonatal care in developed
    countries, 40% of neonates with sepsis die or experience a major disability
    such as neurodevelopmental impairment.

    • In 2017, newborn deaths further increased and accounted for 45% of under-five
    deaths globally.

    • In the Philippines, report from the UNICEF showed that neonatal sepsis
    accounts for 13% of neonatal deaths and 10-12% of all causes of deaths in
    the country.
    • Common laboratory tests such as complete blood count, C-reactive
    protein, and erythrocyte sedimentation rate are used to aid in diagnosis,
    even if they have limited diagnostic accuracy for neonatal sepsis.

    • The gold standard for diagnosing neonatal sepsis is still blood culture
    despite its low sensitivity - majority of sepsis cases are diagnosed in the
    presence of concerning clinical signs with negative culture results.
    • The limitations of ancillary tests and the low sensitivity of blood culture
    combined with non-specific clinical signs constrain clinicians to treat
    patients based on a high level of suspicion.

    • This necessitates initiation of empiric antibiotic therapy until sepsis is


    ruled out.
    • The diversity of organisms causing neonatal sepsis varies from one
    hospital to another and can change over time in the same location.

    • Although most isolates remain sensitive to newer antibiotics,


    emergence of resistant strains is a potential problem due to changing
    patterns of antibiotic use.
    • The subtle and non-specific symptomatology of sepsis causes difficulty in
    early detection and timely treatment.

    • The pathogens causing sepsis in the newborn and the antibiotic


    susceptibility varies from one hospital to another.

    • Prompt treatment based on a rational protocol according to antibiotic


    susceptibility will greatly help in reducing morbidity and mortality from
    neonatal sepsis.
    • The risk of overuse of antibiotics are well described in the era of antibiotic
    resistance and the negative effects of altering the microbiome include an
    increased rate of serious complications including mortality and necrotizing
    enterocolitis association with antibiotic exposure.
    LOCAL SETTING
    (VALENZUELA MEDICAL CENTER)

    2021..

    • 300 blood culture requested in


    neonates suspected with
    neonatal sepsis.

    • 12 neonatal mortalities.
    GENERAL OBJECTIVES
    To determine the most common bacterial pathogens, their
    etiology, and their antibiotic susceptibility pattern of neonatal sepsis in
    Valenzuela Medical Center from January 1 to December 31, 2021.

    SPECIFIC OBJECTIVES
    1. To determine the bacteriologic profile of blood cultures of neonates
    diagnosed with neonatal sepsis.
    2. To determine the antibiotic susceptibility pattern of the top
    microorganisms of neonates diagnosed with neonatal sepsis.
    3. To detect the positivity rate of blood culture specimens from neonates
    diagnosed with neonatal sepsis.
    4. To determine the risk factors associated with neonatal sepsis.
    5. To identify clinical presentations of patients clinically diagnosed with
    neonatal sepsis.
    RESEARCH QUESTION
    What are the most common bacterial etiology and their antibiotic
    susceptibility pattern of neonates diagnosed with neonatal sepsis in
    Valenzuela Medical Center from January 1 to December 31, 2021?
    HYPOTHESIS
    NULL HYPOTHESIS
    There are no commonly identified bacteria with their antibiotic
    susceptibility pattern in neonates diagnosed with neonatal sepsis in
    Valenzuela Medical Center.

    ALTERNATIVE HYPOTHESIS
    There are commonly identified bacterial with their antibiotic
    susceptibility pattern in neonates diagnosed with neonatal sepsis in
    Valenzuela Medical Center.
    SIGNIFICANCE OF THE STUDY

    • Provides guidance to clinicians for empiric therapy of infection before the


    causative agent has been identified.

    • Provides direct therapy after an organism has been identified but before
    susceptibility tests have been completed.

    • Promotes cost-efficient medical management.

    • Increase survival rate of neonates with sepsis.

    • The pathogens causing sepsis in the newborn and the antibiotic susceptibility
    varies from one hospital to another. Prompt treatment based on a rational
    protocol according to antibiotic susceptibility will greatly help in reducing
    morbidity from neonatal sepsis.
    OPERATIONAL DEFINITION

    1. Antibiotics- a drug that inhibits growth of a bacteria.


    2. Blood culture (Positive)- growth of bacteria detected in the blood
    specimen after 4 days of incubation.
    3. Blood culture (Negative)- absence of bacterial growth in the blood
    specimen after 4 days of incubation.
    4. Clinical Sepsis- the presence of infection which requires the following
    criteria: Hypothermia (<36), poor feeding, distended abdomen, apneic
    episodes, grunting, central cyanosis, jaundice. Not necessary
    documented by positive blood culture.
    5. Culture Positive Sepsis- generalized bacterial infection documented by
    a positive blood culture.
    6. Neonates- a child under 28 days of age.
    OPERATIONAL DEFINITION

    7. Antibiotic Resistance- ability of bacteria to resist inhibitory effect of


    potential antibiotics.
    8. Antibiotic Sensitivity- ability of an antibiotic to inhibit bacterial growth.
    9. Neonatal sepsis- generalized bacterial infection in the first 28 days of life,
    characterized by systemic signs of infection.
    10. Bacterial etiology- bacteria identified thru blood culture.
    11. Systemic Inflammatory Response Syndrome (SIRS) – requires either
    abnormal WBC count or abnormal core temperature (>38.5 or <36)
    REVIEW OF
    RELATED
    LITERATURE
    METHODOLOGY
    RESEARCH DESIGN AND SETTING

    This will be a retrospective descriptive study of neonatal sepsis cases in


    Valenzuela Medical Center from January 1 to December 31 2021.
    INCLUSION CRITERIA

    • All neonates admitted in Valenzuela Medical Center from January 1 to


    December 31, 2021 that were clinically diagnosed with suspected
    neonatal sepsis.

    • Neonates who had blood culture and sensitivity done before antibiotics
    were started.
    EXCLUSION CRITERIA

    • Neonates who received antibiotics prior to hospital admission.

    • Neonates with blood culture results done in an institution other than


    Valenzuela Medical Center.
    DATA COLLECTION

    • In-patient records of neonates who were admitted and clinically


    diagnosed with neonatal sepsis will be reviewed and analyzed.

    • Details in the history including maternal risk factors, mode of delivery,


    gestational age, birth weight, birth setting, and clinical manifestations will
    be recorded.

    • Data on Antimicrobial etiology, blood culture and sensitivity will be


    recorded.
    SAMPLE POPULATION

    The sample size will be taken using a census


    (complete enumeration). A total census will be
    taken from the year January 1, 2021 to December
    31, 2021. All documents qualified in our inclusion
    criteria will be used for the study.
    ALTERNATIVE SAMPLE SIZE
    DETERMINATION

    Assuming a confidence level of 95 % and a confidence interval of 5 on a


    300 sample population, 169 is the recommended sample size given the
    conditions selected.
    STATISTICAL TOOL

    Descriptive statistics will be used in the data analysis.


    To determine the susceptibility between the microorganisms to the different
    antibiotics, Chi-square will be used with the following formula:

    Where:
    X2 is the Chi-Square value
    O is the observed frequency
    E is the expected frequency
    ETHICAL CONSIDERATION

    • The study will involve de-identified data on patient profile, blood culture
    and sensitivity results from previously managed VMC patients to be
    retrieved from hospital records and microbiology section, thus posing no
    risk on subjects involved.

    • The study protocol will be submitted to VMC’s Ethics Review Board for
    approval prior to data gathering.
    PRESENTATION,
    ANALYSIS AND
    INTERPRETATIO
    N OF RESULTS
    (DUMMY
    TABLES)
    TABLE 1. GENDER DISTRIBUTION

    TOTAL SUSPECTED CULTURE POSITIVE CULTURE NEGATIVE

    MALE

    FEMALE

    TOTAL
    TABLE 2. DISTRIBUTION BASED ON
    PRESENTING CLINICAL SIGNS
    CLINICAL FEATURE SUSPECTED CASE Culture Positive Culture Negative
    Respiratory distress
    Fever
    Jaundice
    Poor feeding
    Lethargy
    Vomiting
    Diarrhea
    Cyanosis
    Apnea
    TABLE 3. DISTRIBUTION BASED ON
    ASSOCIATED RISK FACTORS
    RISK FACTORS SUSPECTED CASE Culture Positive Culture Negative
    PROM
    MATERNAL
    CHORIOAMNIONITIS
    Non-institutional
    delivery
    Prolonged use of iv
    catheters
    Prolonged
    hospitalization
    Low birth weight
    Preterm
    TABLE 4. Frequency of bacterial isolates

    Bacteria Frequency Total


    Gram positive
    Staphylococcus aureus
    GBS

    Gram Negative
    Klebsiella
    E.coli
    Enterobacter cloacae
    TABLE 5. ANTIBIOTIC SUSCEPTIBILITY
    PATTERN

    ANTIBIOTIC BACTERIA 1 BACTERIA 2 BACTERIA 3


    BUDGET
    AMOUNT

    Statistician 10,000

    Office materials 2,000

    Services 2,000
    - Computer use, data storage
    - - duplication services (reports, etc)

    total 14,000
    TIMETABLE
    Activities (2021) APRIL 2022 MAY 2022 JUNE 2022 JULY 2022 AUGUST 2022

    Approval of
    protocol by
    Ethics Review
    Board

    Data collection

    Data analysis

    Submission of
    final paper
    THANK YOU !

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