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CTRI Number  CTRI/2025/04/085189 [Registered on: 21/04/2025] Trial Registered Prospectively
Last Modified On: 19/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   TO ASSESS THE IMPACT OF ORAL DECONTAMINATION WITH CHLORHEXIDINE (0.2%) VS NORMAL SALINE ON INCIDENCE OF VENTILATOR ASSOCIATED PNEUMONIA IN MECHANICALLY VENTILATED CHILDREN: AN OPEN LABEL PARALLEL GROUP RANDOMIZED CONTROLLED TRIAL  
Scientific Title of Study   To assess the impact of oral decontamination with chlorhexidine (0.2%) vs normal saline on the incidence of ventilator-associated pneumonia in mechanically ventilated children: an open-label parallel-group randomized controlled trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deependra Singh 
Designation  Junior resident 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Resident Hostel, AIIMS Jodhpur, Basni Industrial Phase 2

Jodhpur
RAJASTHAN
342005
India 
Phone  7895920979  
Fax    
Email  iamdeependra16@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Daisy Khera 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Department of Paediatrics, All India Institute of Medical Sciences, Basni Industrial Phase 2

Jodhpur
RAJASTHAN
342005
India 
Phone  8931051245  
Fax    
Email  daisykhera78@gmail.com  
 
Details of Contact Person
Public Query  
Name  Daisy Khera 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Department of Paediatrics, All India Institute of Medical Sciences, Basni Industrial Phase 2

Jodhpur
RAJASTHAN
342005
India 
Phone  8931051245  
Fax    
Email  daisykhera78@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Jodhpur, Rajasthan, 342005 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Jodhpur 
Address  All India Institute Of Medical Sciences(AIIMS), Basni Industrial Area Phase 2 Jodhpur 342005, Rajasthan, India 
Type of Sponsor  Research institution and hospital 
 
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 Deependra Singh  All India Institute of Medical Sciences, Jodhpur  Department of Paediatrics, 2nd Floor, Academic Block, AIIMS Jodhpur, Basni Industrial Area Phase 2 Jodhpur 342005, Rajasthan
Jodhpur
RAJASTHAN 		 7895920979

iamdeependra16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, All India Institute of Medical Sciences, Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J95||Intraoperative and postproceduralcomplications and disorders of respiratory system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CHLORHEXIDINE (0.2%)  Chlorhexidine 0.2% will be used for oral decontamination in the intervention group, administered 4 times per day. Under details, please note: dose – 0.2%, frequency – 4 times/day (q 6hrly), route of administration – oral, total duration of intervention – from the time of intubation till extubation of the patient. 
Comparator Agent  NORMAL SALINE(0.9%)  Normal Saline 0.9% will be used for oral decontamination in the intervention group, administered 4 times per day. Under details, please note: dose – 0.2%, frequency – 4 times/day (q 6hrly), route of administration – oral, total duration of intervention – from the time of intubation till extubation of the patient. 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  17.00 Year(s)
Gender  Both 
Details  1) Children between 1 month to 17 years receiving mechanical ventilation 2) Parents or guardians giving informed written consent for enrolment of children into study.
 
 
ExclusionCriteria 
Details  1. Children who are transferred to our hospital already intubated.
2. Children with primary or acquired immunodeficiencies
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the incidence of ventilator associated pneumonia in mechanically ventilated children randomly allocated to be given oral chlorhexidine (0.2%) or NS.  Incidence of Ventilator associated pneumonia to be calculated at the time of outcome of patient(Discharge/Death/LAMA). 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the duration of mechanical ventilation in both groups  Until the patient is extubated;
 
To compare PICU mortality in each group  Until the outcome (death, discharge or LAMA) 
To compare Hospital mortality in each group  Until the outcome (death, discharge or LAMA) 
Length of PICU stay  Until the outcome (death, discharge or LAMA) 
Length of hospital stay  Until the outcome (death, discharge or LAMA) 
 
Target Sample Size   Total Sample Size="186"
Sample Size from India="186" 
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   Phase 3 
Date of First Enrollment (India)   30/04/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [iamdeependra16@gmail.com].

  6. For how long will this data be available start date provided 03-04-2025 and end date provided 03-04-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Ventilator-associated pneumonia (VAP) is a hospital-acquired infection affecting the lower respiratory tract in individuals on mechanical ventilation, typically manifesting > 48 hours after ventilation initiation. Its correlation with prolonged ventilator requirement, extended stays in intensive care and hospitals, increased mortality rates, and substantial financial burdens are evident.

During critical illness, the stomach is often colonized by Gram-negative bacteria, Streptococcus spp. and Candida albicans, which, by gastrointestinal reflux, colonize the oral cavity. In cases of VAP, the germs isolated in oral secretion and sputum are the same. In addition, pre-existing dental disease is associated with community-acquired pneumonia and hospital-acquired pneumonia. Thus, in VAP prevention bundles, oral hygiene is an important strategy to minimize the chance of tracheobronchitis and pneumonia.

Despite meta-analyses and randomized controlled trials revealing mixed results, the effectiveness of chlorhexidine mouthwash in preventing VAP is yet to be proven.

 

 
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