Rickard 1989.

Methods	RCT Parallel design Single‐centre ‐ Riley Hospital for Children ‐ enrolled between July 1979 and May 1985 USA
Participants	AGE CPN ‐ median 2 years 6 months PPN and EN ‐ median 6 years 6 months SEX CPN ‐ 7 male, 3 female PPN and EN ‐ 7 male, 2 female DISEASE STATUS All malnourished with newly diagnosed Wilms' tumour stage 1 to 5 Only malnourished patients considered HNR were randomised HNR = Stage 2 to 5 disease who: 1) were treated with NWTS protocol 3, i.e. operation, intense chemotherapy and abdominal radiation; or 2) were severely malnourished with > 15% weight loss CHEMOTHERAPY All patients received chemotherapy and all but one CPN patient received additional radiotherapy
Interventions	19 patients randomly assigned: CPN ‐ n = 10, PPN and EN ‐ n = 9 EN ‐ consisted of age appropriate counselling, nutritious favourite foods and oral supplements. Favourite foods and supplements were offered during chemotherapy‐free period to reduce the possibility of conditioned aversion. Vitamin and iron supplements were not used. A concerted effort was made to provide adequate EN for patients who received PPN. CPN patients who had catheter interruptions received PPN plus EN support during this period. CPN ‐ provided a synthetic nutrient mixture of 25 g/dl glucose, 2.55 g/dl crystalline amino acids and a multivitamin infusion. An intravenous fat emulsion was administered (2 g lipid/kg/day) 3 times per week. Nutrients were administered through a silastic central intravenous catheter placed into the superior vena cava just above the right atrium. PPN ‐ consisted of 12.5 g/dl glucose and 2.55 g/dl crystalline amino acid solution. Concentrations of vitamins and minerals were similar to those provided in the CPN solution. Nutrients were administered through an intravenous catheter into peripheral veins. Intralipid was administered through a Y‐connector at a concentration of 10 g/dl and initiated at a rate of 2 g/kg/day. CHEMOTHERAPY/RADIOTHERAPY All patients received radiotherapy and all but 2 patients received additional chemotherapy.
Outcomes	Primary outcomes Change in nutritional indices ‐ Mean daily weight changes ‐ Mean percentage change in weight ‐ Mean percentage change in triceps skinfold ‐ Mean percentage change in subscapular skinfold ‐ Mean change in serum albumin ‐ Mean change in pre‐albumin Adverse events ‐ Number of positive blood cultures ‐ Number of patients with diarrhoea Calorie and nutritional intake ‐ Mean percentage change in energy intake ‐ Mean protein intake Secondary outcomes ‐ Number of deaths
Notes	In HNR children were randomised to receive either CPN or PPN for approximately 4 weeks of initial intense treatment followed thereafter by EN up to 26 weeks. CPN for 4 weeks, then EN up to 26 weeks PPN and EN for 4 weeks, then EN up to 26 weeks
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "patients were randomized" Comment: actual method of randomisation not described
Allocation concealment (selection bias)	Unclear risk	Comment: methods not described
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: Clinician/person delivering treatment: not possible (CPN/PPN/EN obvious) Participants: not possible (CPN/PPN/EN obvious)
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Comment: Outcome assessor: not discussed All outcomes objective, so unlikely to influence outcome measurements
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: Patients randomised: CPN n = 10 PPN & EN n = 9 Withdrawals described CPN n = 3 PPN & EN n = 3 6 patients excluded from short‐term analysis at 4 weeks ‐ 5 excluded because of inability to adhere to nutritional protocol and 1 excluded because of fluid limitations Patients analysed: CPN n = 7 PPN and EN n = 6 As not all patients were analysed and no imputation undertaken, an intention‐to‐treat analysis was not performed.
Selective reporting (reporting bias)	Low risk	Comment: outcomes described in trial as being measured but results not reported: None ‐ all outcomes measured are reported upon either in graphical form or in the text. Although weekly measurements taken, some are reported as % changes and some actual changes
Other bias	Low risk	Comment: None noted