Ventilator associated pneumonia in neonates

Not yet recruiting

Conditions: Influenza and pneumonia,

Registration Number: CTRI/2019/03/017912

Lead Sponsor: Amrit Tuteja

Brief Summary: Ventilator Associated Pneumonia (VAP) is a common complication among mechanically ventilated neonates in neonatal intensive care unit (NICU). This nosocomial infection has a large impact on neonatal morbidity, survival, hospital costs and duration of NICU stay. In most situations, therapy for VAP is empirical and not guided by any definite microbiological isolates. Uniform criteria for diagnosis, identification of significant risk factors, reports of common clinical features, along with descriptions of microbiological profile can aid in early diagnoses and guide treatment. This can potentially reduce exposure to prolonged and inappropriate antibiotic therapy and improve outcomes. We designed this study to enumerate the etiological profile of VAP in neonates with the added benefits of blood PCR for microbiological diagnosis. The use of PCR leads to an increase in diagnostic sensitivity, especially in micro-organisms that cannot be easily cultured and in case of a low burden of micro-organisms with previous antibiotic therapy. This prospective descriptive study will be conducted in the Level 3B accredited (NNF) NICU of a tertiary care referral centre. All the neonates who require respiratory support for more than 48hrs and suspected to have VAP as per Neo-KISS protocol definitions will be included. Sepsis profile along with Blood culture, Blood PCR and ET sample (if obtainable) for culture and gram stain and X-ray chest will done in those suspected to have VAP. Antibiotics will be started or upgraded as per the antibiotic policy of our unit. Etiological profile of VAP will be described according to Blood culture and PCR findings. Tracheal aspirate will be correlated with blood culture and blood PCR. We also seek to study the possible predictors and clinical pointers of VAP and evaluate response to empiric antibiotic change.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 70

Inclusion Criteria

All inborn and outborn neonates satisfying the following criteria will be included in the study: 1.Who require ventilator support for more than 48hrs duration, AND 2.Needing change of antibiotic AND 3.Fulfilling the criteria of VAP as per Neo-KISS protocol.

Exclusion Criteria

1.Parents not willing to be a part of the study 2.Major cardiac or pulmonary congenital malformations 3.HIV positive mothers.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Microbiological profile (proportion of various microbes) in Blood culture or Blood PCR in babies with VAP. If blood culture and PCR are negative, ET will be considered to label etiology.	Till discharge

Secondary Outcome Measures

Name	Time	Method
1.To evaluate incidence of definite, probable and possible VAP in neonates.	2.Failure of empiric antibiotic therapy (clinical and mirobiological)

Trial Locations

Locations (1): KIMS hospital, Trivandrum
🇮🇳
Thiruvananthapuram, KERALA, India
KIMS hospital, Trivandrum
🇮🇳Thiruvananthapuram, KERALA, India
Amrit Tuteja
Principal investigator
9818019996
amrittuteja@rediffmail.com