Sebastian 2012.

Methods	Study design: Double‐blind stratified placebo‐controlled RCT Location: New Delhi, India Number of centres: 1 Study period: November 2007 to April 2009 Funding source: Indian Council of Medical Research Grant. Chlorhexidine gel and placebo supplied by ICPA Health Products Limited
Participants	Setting: Paediatric ICU (6 beds) Inclusion criteria: Patients aged 3 months to 15 years who required orotracheal or nasotracheal intubation and mechanical ventilation. Patients with pneumonia at baseline were also included as these made up 66% of patient population Exclusion criteria: Patients mechanically ventilated for > 48 hours prior to paediatric ICU admission, those with tracheostomies, with inaccessible oral cavities, or with known hypersensitivity to chlorhexidine Number randomised: 86 (41/45) Number evaluated: 86 Baseline characteristics: ‐ Intervention group: Age: 13/41, 3 ‐ 12 months; 28/41, 1 year ‐ 15 years; M/F: 23/18 ‐ Control group: Age: 15/45, 3 ‐ 12 months; 30/45, 1 year ‐ 15 years; M/F: 27/18
Interventions	Comparison: Chlorhexidine gel versus placebo Experimental group (n = 41): Oral cavity was suctioned to remove secretions then mucosal surfaces were cleaned with saline soaked gauze. Then 0.75 cm 1% chlorhexidine gel was applied to each side of the mouth using a standardised disposable applicator Control group (n = 45): Oral cavity was suctioned to remove secretions then mucosal surfaces were cleaned with saline soaked gauze. Then 0.75 cm placebo gel was applied to each side of the mouth using a standardised disposable applicator Care was repeated every 8 hours
Outcomes	1. Incidence of VAP 2. Length of stay in ICU 3. Duration of hospital stay 4. Hospital mortality 5. Type and antibiotic sensitivity of organisms cultured
Notes	Sample size calculation: Estimated that 91 participants per group were required to give 80% power with α = 5% to detect a reduction in VAP from 40% to 20% NCT00597688 at ClinicalTrials.gov This study included participants with pneumonia at baseline and used age‐appropriate CDC criteria to diagnose VAP
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Eligible participants were stratified into 1 of 4 groups based on age group and presence or pneumonia at baseline. Within each stratum participants were randomised to receive either chlorhexidine or placebo gel. "..the random sequence was generated for each stratum using STATA 9.0 in blocks of 6"
Allocation concealment (selection bias)	Unclear risk	No details about how the allocation was communicated to the researchers
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double blind
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Double blind
Incomplete outcome data (attrition bias) All outcomes	Low risk	All randomised participants included in the ITT analysis
Selective reporting (reporting bias)	Low risk	All planned outcomes reported. Medians and IQRs (as reported) are the correct statistic for a skewed distribution but cannot be combined in meta‐analysis
Other bias	Low risk	Paper states that "the funding agency did not have any role in the study design, data collection and analysis, decision to publish or preparation of the manuscript"