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Neonatal SEPSISnicu etaNCT03310840

A Study on Ventilator-associated Pneumonia as a Risk for Nosocomial Infection in Mechanically Ventilated Neonates In NICU of Assiut University Children Hospital (Nicu Eta)

An observational study of Neonatal SEPSIS and Nosocomially Acquired Neonatal Sepsis, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 3 days to 2 monthsHealthy volunteers can take part
What is being tested?
others
How many people
140 participants
Where
1 siteEgypt
Study dates
1 Apr 2018to 1 Oct 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 days to 2 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: porotocal of thesis ;

Who may be able to join

  • Characteristics: all cases All neonate admitted NICU of assiut University Children Hospital , who required endotracheal intubation and mechanical ventilation, regardless neonatal age.
  • Target population, in details : all cases which develop neonatal sepsis on mechanically ventilate neonate admitted in NICU.of assiut university children hospital during the period from January 2018 to December 2018.

Who cannot join

  • meconium aspirated pneumonia .
  • Neonates ventilated for infectious

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Assuit University NICU of Children Hospital

    Asyut

Other trials in Egypt

About this study

Official title: A Observational Study on Ventilator-associated Pneumonia as a Risk for Nosocomial Infection in Mechanically Ventilated Neonates In NICU of Assiut University Children Hospital PROTOCOL OF THESIS Descriptive Study

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.

Read the detailed 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:
  3. General physical assessment.
  4. Gestational age.
  5. Growth measurements.
  6. Vital data.
  7. General appearance. ii. Systems assessment. <!-- -->
  8. Neurological Examination.
  9. Respiratory Examination.
  10. Cardio-vascular Examination.
  11. 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
  12. Investigation:
  13. Imaging study chest x-ray on admission\& follow up, ultrasound, CT scan when indicated.
  14. Complete blood count, capillary blood gases. C) Septic screening
  15. Initial evaluation inflammatory mediator (C-reactive protein)
  16. Blood culture.
  17. 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: <!-- -->
  18. Full agreement: when the same strain of organism has been isolated from the blood and endotracheal tube aspirate cultures,
  19. Partial agreement: when the organisms in the blood were found as one of the multiple isolates from the endotracheal tube,
  20. No agreement: when the organism was found in the endotracheal tube aspirate and blood was not the same,
  21. 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.

Being tested
others
Medical subject headings
Neonatal Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • othersOther

    others

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mechanical ventilation accused to be risk factor for nosocomial infection in neonate .

    to determine incidence and prevalence of neonatal sepsis on mechanically ventilated neonate

    Measured: from april 2018 to march 2019

Secondary outcomes (1)
  1. value of Surveillance program

    serial endo tracheal aspirate ever three day to predict neonatal sepsis and type of organisms causing sepsis in ventilated neonate,antibiotic proper usage

    Measured: from april 2018 to march 2018

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2017
  2. Study start1 Apr 2018
  3. Primary completion30 Mar 2019
  4. Study completion1 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03310840
Sponsor's protocol ID
PROTOCOL OF THESIS
Acronym
nicu eta
Status last verified
Dec 2020
First submitted
25 Sep 2017
Last updated
23 Dec 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Neonatal SEPSIS and Nosocomially Acquired Neonatal Sepsis, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mechanical ventilation accused to be risk factor for nosocomial infection in neonate . (time frame: from april 2018 to march 2019). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2020.

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