Rickard 1985.
Methods | RCT Parallel design Single‐centre ‐ Riley Hospital for Children ‐ patients enrolled between December 1978 and March 1983 USA | |
Participants |
AGE
Age range 6 months to 10 years
CPN ‐ range 1 year to 10 years 6.5 months
PPN and EN ‐ range 1 year 3 months to 5 years 6 months SEX CPN ‐ 6 male, 4 female PPN and EN ‐ 4 male, 4 female DISEASE STATUS Stage 3 or 4 neuroblastoma Details of primary site for each patient:CPN ‐ 7 abdominal, 3 other PPN and EN ‐ 7 abdominal, 1 other Only malnourished patients randomised CHEMOTHERAPY/RADIOTHERAPY All patients received chemotherapy and 7 of 10 CPN patients and 3 of 8 PPN and EN patients received additional radiotherapy |
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Interventions | 18 patients randomly assigned: CPN ‐ n = 10, PPN and EN ‐ n = 8 EN ‐ consisted of age‐appropriate counselling, nutritious favourite foods and oral supplements. Supplements were offered during chemotherapy‐free periods to reduce the possibility of conditioned aversion. Neither vitamin nor iron supplements were used. CPN ‐ consisted of synthetic nutrient mixture of 25 g/dl glucose, 2.55 g/dl crystalline amino acids and multivitamin infusion. Some patients received FreAmine II and some received FreAmine III when FreAmine II became unavailable. Trace elements were provided according to the American Medical Association guidelines. Nutrients were administered through a silastic central venous catheter placed into the superior vena cava. One milligram of AquaMEPHYTON was given weekly by intramuscular injection and intravenous fat emulsion was administered 3 times a week. Concentrations of glucose and rate of administration were increased over a 5 to 7 day period to provide an arbitrary goal of 100% of the 50th percentile energy intake of healthy children of a similar age. PPN ‐ consisted of a 12.5 g/dl glucose and 2.55 g/dl crystalline amino acid solution. Concentrations of vitamins and minerals were similar to that provided by CPN solution. Nutrients were administered through an intravenous catheter into peripheral veins. Intralipid was administered via a Y‐connector at a concentration of 10 g/dl and initiated at a rate of 2 g lipid/kg/day. |
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Outcomes |
Primary outcomes
Change in nutritional indices
‐ Mean change in weight
‐ Height
‐ Mean change in triceps skinfold
‐ Mean change in subscapular skinfold
‐ Mean change in serum albumin Calorie and nutritional intake ‐ Mean change in energy intake ‐ Mean change in protein intake |
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Notes | PN was begun at the onset of therapy and was provided for an average of 28 days through the first 2 cycles of chemotherapy Median length of follow up reported ‐ 10 weeks 14 of 18 malnourished children entered into the study had PN for approximately 4 weeks |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "children were randomized" Comment: actual method of randomisation not described |
Allocation concealment (selection bias) | Unclear risk | Quote: "children were randomized" Comment: actual method of randomisation not described |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: Clinician/person delivering treatment: not discussed (not possible as nasogastric tube obvious) Participants: not discussed (not possible as nasogastric tube obvious) |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: not discussed. All outcomes objective, so lack of blinding unlikely to influence outcome measurements. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: Patients randomised: CPN n = 10 PPN & EN n = 8 Withdrawals described CPN n = 2 due to gross oedema and pleural effusion PPN & EN n = 0 Patients analysed: CPN n = 8 PPN & EN n = 8 No imputation of missing data, therefore intention‐to‐treat analysis not undertaken. As drop outs are not accounted for and may be related to the intervention, there is a high risk of bias. |
Selective reporting (reporting bias) | Low risk | Comment: all outcomes described in trial as being measured are reported |
Other bias | Low risk | Comment: none noted |