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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

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 - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/085189
Enrollment
186
Registered
2025-04-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J95- Intraoperative and postproceduralcomplications and disorders of respiratory system, not elsewhere classified

Interventions

Intervention1: 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%, frequenc

Sponsors

All India Institute of Medical Sciences Jodhpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 1. Children who are transferred to our hospital already intubated. 2. Children with primary or acquired immunodeficiencies

Design outcomes

Primary

MeasureTime frame
To compare the incidence of ventilator associated pneumonia in mechanically ventilated children randomly allocated to be given oral chlorhexidine (0.2%) or NS.Timepoint: Incidence of Ventilator associated pneumonia to be calculated at the time of outcome of patient(Discharge/Death/LAMA).

Secondary

MeasureTime frame
To compare the duration of mechanical ventilation in both groupsTimepoint: Until the patient is extubated; ;To compare PICU mortality in each groupTimepoint: Until the outcome (death, discharge or LAMA);To compare Hospital mortality in each groupTimepoint: Until the outcome (death, discharge or LAMA);Length of PICU stayTimepoint: Until the outcome (death, discharge or LAMA);Length of hospital stayTimepoint: Until the outcome (death, discharge or LAMA)

Countries

India

Contacts

Public ContactDaisy Khera

All India Institute of Medical Sciences, Jodhpur

daisykhera78@gmail.com8931051245

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026