A Study On the Risk of Nosocomial Infection in Mechanically Ventilated Neonate In NICU of Assiut University Children Hospital (Nicu Eta)

A Study On the Risk of Nosocomial Infection in Mechanically Ventilated Neonate In NICU of Assiut University Children Hospital PROTOCOL OF THESIS Descriptive Study

Sponsors

Lead Sponsor: Assiut University

Source Assiut University
Brief Summary

Hospital acquired infection is an important cause of mortality and morbidity among infants in neonatal intensive care units. Surveillance cultures are performed routinely in many units to monitor infants at risk of sepsis.

Mechanically ventilated babies face particular risk because artificial airways bypass the body's defenses against inhaled pathogens and offer new routes for non airborne pathogens. Intubation associated lesions of pharynx and trachea lead to bacterial colonization by the deterioration of the swallowing reflex and the ciliary functions. Subsequently, these babies may develop pneumonia and sepsis.

cultures of aspirates obtained through endotracheal tubes from ventilated infants are monitored on the assumption that the organisms that are colonising the respiratory tract will be the same pathogens as those isolated from the blood during episodes of sepsis.

Detailed Description

introduction Neonatal sepsis is an invasive bacterial infection that occurs in newborns between first and nineteenth day of life. Neonatal sepsis is one of the most frequent causes of morbidity and mortality in newborns[1]. Worldwide, incidence of sepsis in newborns varies between 1- 10 cases per 1000 live births, and the mortality varies between 15-50%[2]. Neonatal sepsis is usually classified as early or late 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 (transplacental infection, ascending infection from cervix and the newborn can acquire the microorganisms as it passes through the birth canal at delivery). Late neonatal sepsis usually occurs due to the lack of aseptic working conditions . the occurrence of late sepsis is considered an important indicator of quality of care [3].

Improvements in antenatal management and neonatal intensive care over the past 10 to 15 years have changed the prognosis for preterm infants. More than 85% of infants born at 25 weeks' gestation now survive their preterm birth.[4-5]

Although advances in neonatal intensive care have led to improved survival of very low birth weight (VLBW) infants, late-onset sepsis continues to be an important cause of morbidity and mortality.[[1-10] The risk of late-onset sepsis increases with decreasing birth weight and age. Ongoing infectious disease surveillance is essential because increasingly immature neonates are being provided with intensive care, require prolonged hospitalization, and are surviving[6-7] .

Hospital acquired infections (nosocomial infections) are the most common complications encountered in the neonatal intensive care units (NICU). They generally manifest 48 hours after hospitalization or in 48 hours after discharge. Especially preterm and low birth weight newborns are more vulnerable (20-33%) to nosocomial infections.[8-9] Mechanically ventilated babies face a particular risk because artificial airways bypass the body's defenses against inhaled pathogens and offer new routes for non airborne pathogens [5]. Intubation associated lesions of pharynx and trachea lead to bacterial colonisation by the deterioration of the swallowing reflex and the ciliary functions. Subsequently, these babies may develop pneumonia and sepsis[10] .

Hospital acquired infection is an important cause of mortality and morbidity among infants in neonatal intensive care units. Surveillance cultures are performed routinely in many units to monitor infants at risk of sepsis.[1-10]

Incidence& Epidemiology A significant proportion of neonates admitted to NICU require mechanical ventilation; accounts for up to 30% of nosocomial infections Ventilator-associated sepsis in neonatal intensive care unit (NICU) [11,12] Mechanically ventilated neonates have a high fatality. Survival rate in artificially ventilated neonates is reported as 64% by Trotman[16] and 67.9% by Karthikeyan and Hossain[17] though survival of such neonates has been higher in developed countries.[18] The most common reasons for mechanical ventilation were respiratory distress syndrome (70%) and perinatal asphyxia (14%)[19]. None of the infants intubated had radiographic evidence of pulmonary infection at initiation of ventilatory support[20].

Risk factor& PATHOGENESIS For nosocomial respiratory tract infections to occur, the delicate balance between host defenses and microbial propensity for invasion must shift in favor of the capability of pathogens to establish pneumonia, sepsis .

Risk for these infections is determined in part by the duration of exposure to the health care environment and in part by a number of host factors and treatment-related factors.

Prematurity , Birth weights , Intubation and re-intubation , Duration of mechanical ventilation, Suction , Aspiration and nutrition, Modulation of colonization, Systemic antibiotics , Ventilator circuit-related factors. [21] AEtiology infants who developed sepsis pathogens isolated from blood were compared with the organisms isolated from ETA. the same strain of organism has been isolated from the blood and endotracheal tube aspirate cultures(full agreement). the organisms in the blood were found as one of the multiple isolates from the endotracheal tube(partial agreement). same organism was not found in the endotracheal tube aspirate and blood(no agreement )

Research Methods and techniques:

- Type of the study: ; Thesis;observational study.

- Study Setting: ; The study was conducted at NICU. of Assiut university children hospital

- Study subjects:

a. Inclusion criteria:

- Characteristics: all cases All neonate admitted NICU of Assiut University Children Hospital , all who required endotracheal intubation and mechanical ventilation.

- Target population, in details : all cases which develop neonatal sepsis on mechanically ventilated neonate admitted in NICU.of Assiut university children hospital during the period from April 2018 to March 2019 b. Exclusion criteria: 1-Neonates ventilated with Evidence of neonatal sepsis before ventilated. 2- meconium aspiration syndrome were excluded. c. Sample Size Calculation: Neonate who develop sepsis after intubation and mechanical ventilation

- Neonates In our study were classified into two groups; i. Group A: cases with suspected VAP ii. group B: cases without VAP

- Neonates with suspected VAP in NICU of ASSIUT : were diagnosed as VAP according to: ( Modified CDC guidelines for infants≤1 year old ,2013) .

- Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …):

All patient will be subjected to A. History include i. Personal Data; Name, Hospital Serial No, sex , single or twins or more , Birth Data, Gestational age . stress full condition, risk factors .

ii. Prenatal history; Maternal illness ,Fever , Maternal intake of drug , Ante partum Hge, P.ROM , Diabetes mellitus, Preclampsia, prenatal steroid.

iii. Family history ; Mather Name , Father Name , Consanguinity, No of pregnancies , No of deliveries , Parity, Stillbirth , Abortion , previous congenital anomalies .

iv. obstetric history( natal &post natal); place of delivery ,attending person, mode of delivery, sedation &anesthesia , Evidence of fetal distress (Fetal Brady cardiac, Late decelerations , Meconium stained liquor), Apgar score, resuscitation(need of E.T.T), invasive procedures ..

B. Full clinical examination. i. General physical assessment.

1. Gestational age: (Ballard score) ,(intra uterine growth , maturity sign).

2. Growth measurements: weight , length, head circumference

3. Vital data : (temperature , heart rate , blood pressure , respiratory rate, sao2).

4. General appearance: observe & record activity &obvious congenital abnormalities. Skin color & texture &any abnormal condition .Head and neck assessment & Extremities & Back and spine ii. Systems assessment.

1. Neurological Examination: neonatal reflexes ,activity ,level of consciousness ,tone . pupil , fontanel's , seizures.

2. Respiratory Examination: skin color ,work of breathing ,breath sounds ,secretions ,pulse oximeter.

3. Cardio-vascular Examination: heart sounds ,rhythm , murmurs ,peripheral pulses.

4. Abdominal Examination: shape , abd girth , umbilical stump , skin , palpation for any organs or tenderness , percussion, auscultation for bowel sounds

Investigation . Laboratory evaluation of the infant with suspected infection is a critical component of their care imaging study chest x-rays on admission (Sonar ,Ct Scan) when indicated. complete blood count ,serum electrolytes(Na ,K ,Ca ,Mg),kidney function , liver functions, arterial blood gases , RBG confirmed by lab test ,they are non specific marker of inflammation. also very helpful in evaluating the infant with suspected infection.

septic screening , Initial evaluation should include a blood culture, urine culture, and culture of bronchoalveolar lavage. These studies can provide a definitive source and causative organism in infected infants.

,inflammatory mediator (C-reactive protein ,others) when admitted negative neonate will be included bronchial aspirate for culture after the third day every three day then weekly until extubation [13,14] for neonate who clinically ,physically,chemically developing sign suggesting sepsis Antibiotic sensitivity test will be done to all culture[15].

-Data management and analysis: Data collection Computer software Statistical tests

Data analysis Data was processed and analysis using Spss software v16. Data will be presented in the mean ±SD and percent. Data will be expressed by student test and icqu square.

Part 3: Ethical Considerations (Written in details taking in consideration the items below):

. Risk - benefit assessment.

. Confidentiality (dealing with data and data dissemination should be confidential).

. Statement describing the research procedure to be given to the participants.

. Informed consent.

.• Reviewing the proposal starting via the ethical committee of Assiut Faculty of Medicine.

- The aim of the study was explained to the parent before starting the study.

- Written consent was obtained from those who welcome to participate .

- Privacy and confidentiality of all data assured.

Overall Status Completed
Start Date April 1, 2018
Completion Date October 1, 2019
Primary Completion Date March 30, 2019
Study Type Observational
Primary Outcome
Measure Time Frame
mechanical ventilation accused to be risk factor for nosocomial infection in neonate . from april 2018 to march 2019
Secondary Outcome
Measure Time Frame
value of Surveillance program from april 2018 to march 2018
Enrollment 140
Condition
Eligibility

Sampling Method: Probability Sample

Criteria:

Inclusion Criteria:

- 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.

Exclusion Criteria

- meconium aspirated pneumonia .

- Neonates ventilated for infectious

Gender: All

Minimum Age: N/A

Maximum Age: 2 Months

Healthy Volunteers: Accepts Healthy Volunteers

Location
Facility: Assuit University NICU of Children Hospital
Location Countries

Egypt

Verification Date

April 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Assiut University

Investigator Full Name: Abd Elrhman Fawzy

Investigator Title: M.B.B.CH resident doctor. principal investigator

Has Expanded Access No
Condition Browse
Acronym nicu eta
Study Design Info

Observational Model: Other

Time Perspective: Prospective

Source: ClinicalTrials.gov