Gottschlich 1990.

Methods	Design: randomised controlled trial. Multi‐centre or single‐centre: multi‐centre (Cincinnati Shriners Burns Institute or University Hospital). Period: April 6, 1986, to May 20, 1988. Sample size calculation: not specified. Generation of allocation: random numbers table stratified for age, institution and burn size. Allocation concealment: not reported. Blinded assessment of treatment allocation: Tube feeding was blinded in such a fashion that all physicians, nurses, laboratory technicians and other clinical and research personnel were not aware to which group participants were assigned. Withdrawals: none reported. Intention‐to‐treat analysis: none reported (no withdrawals). Follow‐up: not reported
Participants	50 participants Group 1 control: 14 (11 male, 1 female); group 2 experimental: 17 (14 male, 3 female); group 3 control: 19 (12 male, 7 female) Mean age: group 1, 15.1 years; group 2, 21.3 years; group 3, 21.3 years Mean TBSA: group 1, 38.3%; group 2, 45.0%; group 3, 38.6% Inclusion criteria: acutely burned patients (> 3 years old), burns > 10% TBSA, admitted within 5 days of burn injury
Interventions	Control 1 (group 1): Enteral Osmolite/Promix + Nutrisource Vitamins Experimental (group 2): modular tube feeding recipe; linoleic acid–restricted formulation Protein: Whey 87%; arginine 9%; cysteine 2%; histidine 2% Fats: 50% fish oil (omega‐3 fatty acids); 50% safflower oil Control 2 (group 3): Traumacal (1 kcal/mL) + Nutrisource Vitamins All groups: additional 5000 IU of vitamin A per 1000 mL. All participants also received daily oral supplements of 1 gram vitamin C and 220 mg heptahydrous zinc sulfate (46 mg elemental zinc)
Outcomes	Overall mortality and causes Hospital LOS (days/%burn) Total infectious episodes: bacteraemia + wound infection + pneumonia Clinical sepsis: presence of 3 of the following events: positive blood culture, disorientation, ileus, hypotension, increased fluid requirement, decreased urine output, leukopaenia, hypothermia, metabolic acidosis, thrombocytopenia, decreased progression of wound healing, pulmonary failure, renal failure, hepatic dysfunction, stress ulceration, tachypnoea or tachycardia Bacteraemia: required positive blood culture and clinical need for antibiotic therapy Wound infection: positive wound culture greater than 105 CFU/g tissue, systemic antibiotic treatment or significant graft loss Pneumonia: positive sputum culture with consistent radiographic changes upon chest x‐ray and systemic antibiotic therapy
Notes	Other outcomes: tolerance of tube feeding, days requiring antibiotics, number of ventilator days, number of surgeries, days requiring albumin infusion, biochemical measures, weight
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random numbers table stratified for age, institution and burn size
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding (performance bias and detection bias) All outcomes	Low risk	Tube feeding was blinded in such a fashion that all physicians, nurses, laboratory technicians and other clinical and research personnel were not aware to which group participants were assigned
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	No withdrawals from study. 50 participants included and analysed but not clearly specified
Other bias	Unclear risk	Sample size calculation not reported, ITT not reported, follow‐up not reported