Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03310840 |
| Other study ID # |
PROTOCOL OF THESIS |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2018 |
| Est. completion date |
October 1, 2019 |
Study information
| Verified date |
December 2020 |
| Source |
Assiut University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Abstract
Background: Neonatal ventilator associated pneumonia (VAP) is a major hospital-acquired
infection in acute care settings, associated with high mortality and poor outcome. VAP is
considered a preventable infection if the risk factors are managed effectively. The purpose
of this study is to evaluate prevalence of ventilator associated pneumonia, its causative
organisms, its risk factors and outcome at our NICU.
This study used CDC guidelines for infant's ≤1 year old to diagnose neonatal VAP, in period
from April 2018 to March 2019.
Description:
Background:
Neonatal deaths represent third of the global burden of child mortality [1]. In Egypt,
Infections such as pneumonia, meningitis, sepsis/septicemia and other infections account for
28% of deaths during the neonatal period, Survival cannot be achieved without substantial
reductions in infection-specific neonatal mortality [2]. Neonatal sepsis is usually
classified as early or late onset sepsis. Early sepsis occurs within the first 72 hours of
birth and late neonatal sepsis occurs after 72 hours of birth. Early neonatal sepsis is
associated with acquisition of microorganism from mother Late neonatal sepsis usually occurs
due to the lack of aseptic working conditions [3]. The occurrence of late sepsis is
considered an important indicator of quality of care. Mechanical ventilation is an essential,
life-saving therapy for patients with critical illness and respiratory failure. These
patients are at high risk for complications and poor outcomes, including death,
Ventilator-associated pneumonia (VAP), Sepsis, pulmonary embolism, barotrauma, and pulmonary
edema. Such complications can lead to longer duration of mechanical ventilation, longer stays
in the intensive care unit (ICU) and hospital, increased healthcare costs, and increased risk
of disability and death [4, 5]. Ventilator associated pneumonia (VAP) is defined as a
nosocomial lower airway infection, i.e. pneumonia, in intubated patients with onset after 48
h or more of invasive mechanical ventilation [6]. VAP is usually caused by airway
colonization by potential pathogens; Sources of airway colonization can be the patient's own
flora, i.e., bacterial overgrowth in oral secretions, reflux and aspiration of gastric fluid
or the patient's environment with its caretakers and equipment [7, 8].
Mechanically ventilated babies face a particular risk because artificial airways bypass the
body's defenses against inhaled pathogens and offer new routes for non-air borne pathogens.
Intubation associated lesions of pharynx and trachea lead to bacterial colonization by the
deterioration of the swallowing reflex and the ciliary functions [9].VAP is one of the most
frequently diagnosed nosocomial infections [10] and, after suspected early onset sepsis,
second most reason for antibiotic intervention in Neonatal Intensive Care Unit (NICU) [11,
12].VAP incidence can be reduced by infection control measures such as VAP-prevention-bundles
[13]. Regarding diagnosis of VAP episode requires a combination of radiological, clinical,
and laboratory criteria. However Center for Disease Control and Prevention/ National
Nosocomial Infection Surveillance (CDC/NNIS) criteria refers to infants younger than 1 year
and do not define specific criteria for the newborn period in term or preterm infants. In
spite of this lack of specificity, most studies of VAP performed in NICUs are based on these
criteria [14].
Keywords: Newborn, Mechanical ventilation, ventilator-associated pneumonia, risk factors,
causative organisms.
'Method's: Design: A prospective, observational cohort surveillance, was carried out at our
Neonatal Intensive Care Unit (NICU) was done during a period from April 2018 to March 2019 to
neonates who needed mechanical ventilation, reviewing data of diagnosis of neonates with
ventilation associated pneumonia used .
Setting: Our NICU is a level III, part of a university-teaching hospital, receives referrals
from the whole Upper Egypt. It has approximately 1450 case per year, approximately ~ 5
patients per day. It has approximately 450 case needs MV per year.
Patients:
Inclusion criteria:
All inborn and outborn neonates who were admitted to the our NICU during the April 2018-
March 2019 were screened for study enrollment and were considered eligible if ventilated for
more than 48 hours.
Exclusion criteria:
Neonates ventilated with Evidence of neonatal sepsis before ventilated. Meconium aspiration
syndromes were excluded. Death within 48 hours of NICU admission.
• Neonates In our study were classified into two groups; i. Group A: cases with suspected
VAP. ii. Group B: cases without VAP. Because up to this point we don't know the lab result
and microbiology. The diagnosis should be based on all of the three items of radiologic
signs, clinical signs and Symptoms and microbiological findings Cernada M et al [15].
Intervention:
- Medical records comprising charts, daily flow sheets, laboratory and radiographic
reports were collected prospectively by the investigators.
- Neonates with suspected VAP in NICU: were diagnosed as VAP according to:
(Modified CDC guidelines for infants≤1 year old)[5,6,13].
All patient will be subjected to:
1. Full history taking:
Including: Patient data, Perinatal history, Present history, Family history.
2. Full clinical examination:
i. General physical assessment.
1. Gestational age.
2. Growth measurements.
3. Vital data.
4. General appearance. ii. Systems assessment.
1. Neurological Examination.
2. Respiratory Examination.
3. Cardio-vascular Examination.
4. Abdominal Examination. Then Monitoring of the ventilator settings, and fraction of
inspired oxygen (FIO2).
The clinical criteria for diagnosis; Worsening gas exchange: desaturations pulse
oximetry less than 94%, increase ventilation demand,
And at least three of the following Temperature instability Leukopenia (≤4000 WBC/mm3)
or leukocytosis (>15,000 WBC/mm3) and left shift Band forms (10%) New onset of purulent
sputum or change in character of sputum, or increased respiratory secretions Apnea,
tachypnea, nasal flaring with retraction of chest wall or nasal flaring with grunting
Wheezing, rales, or rhonchi
3. Investigation:
1. Imaging study chest x-ray on admission& follow up, ultrasound, CT scan when
indicated.
2. Complete blood count, capillary blood gases. C) Septic screening
1. Initial evaluation inflammatory mediator (C-reactive protein)
2. Blood culture.
3. Culture of bronchoalveolar lavage: aspirate for culture non-quantitative
cultures after the third day hen weekly until extubation. Antibiotic
sensitivity test will be done to all culture.
We tried to compare the results of BAL versus blood culture in the diagnosis
of VAP according to Cantey JB et al[12] ,aimed to intensive role of BAL.
Microorganisms isolated from blood were compared with that isolated from BAL.
According to results:
1. Full agreement: when the same strain of organism has been isolated from the
blood and endotracheal tube aspirate cultures,
2. Partial agreement: when the organisms in the blood were found as one of the
multiple isolates from the endotracheal tube,
3. No agreement: when the organism was found in the endotracheal tube aspirate
and blood was not the same,
4. Lines of treatment:
- Initial (empirical) therapy is most often begun before a definite causative agent
is identified.
- Continuing therapy is based on culture and sensitivity results, clinical course
Ethical considerations:
The aim of the study was explained to each parents of the child before the beginning of the
process. A written consent was obtained from those who welcomed to participate in the study.
Privacy and confidentiality of all data were assured.
Statistical analysis:
The data were tested for normality using the Kolmogorov-Smirnov test and for homogeneity
variances prior to further statistical analysis. Categorical variables were described by
number and percent (N, %), where continuous variables described by mean and standard
deviation (Mean, SD). Chi-square test used to compare between categorical variables where
compare between continuous variables by t-test (One Way ANOVA). A two-tailed p < 0.05 was
considered statistically significant. All analyses were performed with the IBM SPSS 20.0
software.
