| CTRI Number |
CTRI/2019/03/017912 [Registered on: 05/03/2019] Trial Registered Prospectively |
| Last Modified On: |
02/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Ventilator associated pneumonia in neonates |
|
Scientific Title of Study
|
Etiological profile of ventilator associated pneumonia in neonates-A prospective study. |
| Trial Acronym |
N-VAP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amrit Tuteja |
| Designation |
Senior resident Neonatology |
| Affiliation |
Kerela Institute of Medical Sciences |
| Address |
1, Vinod Nagar Rd, Anayara, Thiruvananthapuram,
Kerala 695029
Thiruvananthapuram
KERALA
695029
India |
| Phone |
9818019996 |
| Fax |
|
| Email |
amrittuteja@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Naveen Jain |
| Designation |
Consultant Neonatology |
| Affiliation |
Kerela Institute of Medical Sciences |
| Address |
1, Vinod Nagar Rd, Anayara, Thiruvananthapuram,
Kerala 695029
Thiruvananthapuram
KERALA
695029
India |
| Phone |
9387814568 |
| Fax |
|
| Email |
naveen_19572@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Naveen Jain |
| Designation |
Consultant Neonatology |
| Affiliation |
Kerela Institute of Medical Sciences |
| Address |
1, Vinod Nagar Rd, Anayara, Thiruvananthapuram,
Kerala 695029
KERALA
695029
India |
| Phone |
9387814568 |
| Fax |
|
| Email |
naveen_19572@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Amrit Tuteja |
| Address |
1, Vinod Nagar Rd, Anayara, Thiruvananthapuram, Kerala 695029 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Amrit Tuteja |
KIMS hospital, Trivandrum |
Neonatology department, NICU, 5th level, Main block, 1, Vinod Nagar Rd, Anayara, Thiruvananthapuram, Kerala 695029
Thiruvananthapuram
KERALA |
9818019996
amrittuteja@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IHEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J09-J18||Influenza and pneumonia, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
1.Parents not willing to be a part of the study
2.Major cardiac or pulmonary congenital malformations
3.HIV positive mothers
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
1.To evaluate incidence of definite, probable and possible VAP in neonates.
2.Failure of empiric antibiotic therapy (clinical and mirobiological)
3.Factors associated with increased risk of VAP in neonates
4.Clinical signs commonly associated with VAP in neonates
|
Till discharge |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/03/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |