Jacomo 2011.

Methods	Study design: Double‐blind placebo‐controlled RCT (NCT00829842) Location: Sao Paulo, Brazil Number of centres: 1 Study period: February 2006 to February 2008 Funding source: Not stated
Participants	Setting: Tertiary care hospital paediatric ICU Inclusion criteria: Children with congenital heart disease undergoing cardiac surgery with or without cardiopulmonary bypass, admitted to paediatric ICU for postoperative care Exclusion criteria: Pre‐operative pneumonia, hypersensitivity to chlorhexidine, congenital or acquired immunodeficiency, refusal to participate Number randomised: 164 Number evaluated: 160 (4 intra‐operative deaths) Baseline characteristics: ‐ Intervention group: Age: median12.2 (0 ‐ 176 months); M/F: 42/45 ‐ Control group: Age: median 10.8 (0 ‐ 204 months); M/F: 35/38
Interventions	Comparison: Chlorhexidine (gargle or swab) versus placebo Experimental group: Oral hygiene with 0.12% chlorhexidine gluconate solution, administered pre‐operatively and twice daily postoperatively. 0.3 ml/kg of body weight were used in children aged > 6 years, who gargled for 30 seconds avoiding ingestion. In younger children and intubated postoperative patients solution was applied to oral mucosa, gingival, tongue and tooth surfaces for 30 seconds with a spatula wrapped in gauze Control group: Received the same treatment with placebo solution that looked and tasted the same All participants received orotracheal intubation and prophylactic systemic antibiotics intravenously for 48 hours
Outcomes	1. Incidence of nosocomial pneumonia 2. Incidence of VAP 3. Duration of intubation 4. Need for reintubation 5. Time to development of pneumonia 6. Length of paediatric ICU/hospital stay 7. 28‐day mortality
Notes	Sample size calculation: Estimated that 160 participants would detect a reduction in 50% in incidence of nosocomial pneumonia (31% to 15.5%) with α = 0.05 & β = 0.20 NCT 00829842 at ClinicalTrials.gov
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"..randomized to the experimental or control groups by means of a list generated by a computerized system that uses a random number generator to produce customized sets of random numbers"
Allocation concealment (selection bias)	Low risk	"The randomisation list was held in the hospital pharmacy and all investigators were unaware of patients assignments"
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double blind. Texture, colour, and flavour of placebo similar to active solution, placed in similar containers and labelled A or B
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Double blind. "..the diagnosis of nosocomial pneumonia was made independently by the PICU physicians and an infection control practitioner blinded to the patient's group"
Incomplete outcome data (attrition bias) All outcomes	Low risk	2 participants in each group died and were therefore excluded from pneumonia outcomes
Selective reporting (reporting bias)	Unclear risk	Planned outcomes clearly reported but unclear how many trial participants were ventilated for at least 48 hours
Other bias	Low risk	No other sources of bias identified