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CTRI Number  CTRI/2025/03/082321 [Registered on: 17/03/2025] Trial Registered Prospectively
Last Modified On: 27/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Study of pneumonia in patients on ventilator life support in very sick children in Pediatric Intensive Care Unit 
Scientific Title of Study   Prospective Study of Frequency, Risk Factors and Outcome of Ventilator-associated Pneumonia in a Tertiary Care Pediatric Intensive Care Unit.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Milind S Tullu 
Designation  Professor 
Affiliation  Seth G.S. Medical College and KEM Hospital 
Address  Department of Pediatrics, Seth G.S. Medical College and KEM Hospital, Old KEM Hospital Building, Ward No. 1, Parel, Mumbai. Mumbai MAHARASHTRA 400012 INDIA

Mumbai
MAHARASHTRA
400012
India 
Phone  9869469974  
Fax    
Email  milindtullu@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Milind S Tullu 
Designation  Professor 
Affiliation  Seth G.S. Medical College and KEM Hospital 
Address  Department of Pediatrics, Seth G.S. Medical College and KEM Hospital, Old KEM Hospital Building, Ward No. 1, Parel, Mumbai. Mumbai MAHARASHTRA 400012 INDIA

Mumbai
MAHARASHTRA
400012
India 
Phone  9869469974  
Fax    
Email  milindtullu@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Koneru Haritha 
Designation  Junior Resident 
Affiliation  Seth G.S. Medical College and KEM Hospital 
Address  Department of Pediatrics, Seth G.S. Medical College and KEM Hospital, Old KEM Hospital Building, Ward No. 1, Parel, Mumbai. Mumbai MAHARASHTRA,INDIA

Mumbai
MAHARASHTRA
400012
India 
Phone  8374424696  
Fax    
Email  doctorharitha@gmail.com  
 
Source of Monetary or Material Support  
Seth G S Medical College and KEM Hospital, Parel, Mumbai 400012, Maharashtra, INDIA 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Milind S Tullu  Seth G.S. Medical College and KEM Hospital  Pediatric Intensive Care Unit, Old KEM Hospital Building, Ward No. 1, Ground Floor, Parel, Mumbai 400012. Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA 		 9869469974

milindtullu@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee IEC II, Seth GS Medical College and KEM Hospital, Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J180||Bronchopneumonia, unspecified organism, (2) ICD-10 Condition: J17||Pneumonia in diseases classified elsewhere, (3) ICD-10 Condition: J22||Unspecified acute lower respiratory infection,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  12.00 Year(s)
Gender  Both 
Details  All consecutive patients admitted to the PICU from the age group of 1 month to 12 years of either gender will be enrolled in the study. 
 
ExclusionCriteria 
Details  Patients whose parents or guardians refuse to give informed consent and children below the age of 1 month or beyond 12 years will be excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
In the patients admitted to the Pediatric intensive care unit to determine the
frequency, outcome, risk factors of ventilator associated pneumonia 		 At discharge frome the PICU or at death of the patient 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   20/03/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Aims & Objectives:

For the patients admitted to a tertiary care Pediatric Intensive Care Unit (PICU) and on mechanical ventilation for  >48 hours --

•  To study the frequency of patients with VAP.

•  To evaluate the risk factors for patients with VAP. 

•  To study the outcome (survival/ death) of patients with VAP.

•  To study the length of PICU stay and length of hospital stay in patients with VAP.

Materials & Methods:

Ethics: The study will be initiated after seeking approval from the “Institutional Ethics Committee (IEC)” of the hospital. The study will be conducted in compliance with the “Ethical Guidelines for Biomedical Research on Human Participants” by the Indian Council of Medical Research.

Consent & Assent: Case enrolment will be done after a written informed consent from the parent/ guardian. Since patients in the PICU are critically ill, the assent will be procured from children aged 7 years and above once their clinical condition stabilizes and when they are in a position to give the assent. 

Study design: Prospective, non-interventional, observational, single-center study.

Study duration: The study will be conducted over a total period of 18 months (prospectively) after approval from the IEC. Enrolment will be done for 12 months or till the expected sample size is reached. Each patient will be in the study till his/ her stay in the PICU.

Study site: The study will be conducted in patients admitted to the PICU of KEM hospital, Mumbai, which is a tertiary care, 14-bedded PICU with state-of-art facilities including mechanical ventilators, non-invasive monitors and other devices for delivering critical care. It is manned by at least 4 resident medical officers round the clock. One Professor looks after the day-to-day clinical and administrative matters of the PICU and is assisted by one Associate Professor and one Assistant Professor. Fellows (MUHS) and senior registrars are also posted in the PICU (when available).

Inclusion Criteria:  All consecutive children aged >28 days to <12 years of either gender on mechanical ventilation for more than 48 hours (intubated either in ward, EPR or PICU) will be included.

Exclusion Criteria: Patients whose parent/ guardian refuse to give informed consent will be excluded from this study. Also patients who die within 48 hours of initiating mechanical ventilation will be excluded.

Confidentiality: The participant’s details will not be disclosed at any point of time.

Total number of patients to be studied (sample size calculation):

• Convenience sampling: All consecutive patients admitted to PICU over a period of 1 year with mechanical ventilation for >48 hours will be enrolled. It has been noticed that the average number of admissions to the Pediatric ICU is around 400 per year. Of these about 340 are ventilated. Of the ventilated patients about 40 die within 48 hours of admission. Hence expected sample size is 300. 

• Each patient will be in the study throughout his/ her PICU stay (till transferred out of PICU/ till death).

• Of the patients enrolled, those who develop VAP will be labelled as the “VAP Group” and those who do not develop VAP will be “No VAP Group”. 

The patient’s daily medical records will be scrutinized from admission until discharge from PICU or until death of the patient. This study will not entail performing any new/ additional investigation or new/ additional treatment or any new/ additional financial burden to the hospital or financial burden to the parent/ guardian.

 Plan for Statistical Analysis:

The following statistical tests will be applied for the various variables and their analysis—

• Age, weight, duration of PICU stay and duration of hospital stay will be expressed as mean, median, mode & SD.

•  Frequency of VAP and Risk factors of VAP will be listed as percentage of total patients enrolled. Frequency of VAP will also be expressed as per 1000 ventilator days (invasive only )

•  Predictors of mortality & LOS will be analyzed by Chi-square test and a p-value less than 0.05 will be considered to be significant.

Expected Outcomes:

This study will help to 

• Determine the current frequency of VAP & its risk factors.

• Understand the mortality and morbidity associated with VAP.

This data will help in planning preventive strategies as well as better treatment strategies for patients developing VAP or patients who are at risk for VAP in the PICU. 




 
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