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. 2015 Aug 24;2015(8):CD003298. doi: 10.1002/14651858.CD003298.pub3

den Broeder 2000.

Methods RCT
 Parallel design
 Single‐centre
 University Hospital Nijmegen, the Netherlands
Participants 27 patients aged 1 to 18 years, newly diagnosed with cancer
AGE 
 EN nasogastric (energy enriched) ‐ 6.5 ± 4.5 years (mean ± SD)
 EN nasogastric (standard) ‐ 5.7 ± 3.8 years (mean ± SD)
SEX 
 EN nasogastric (energy enriched) ‐ 7 male, 8 female
 EN nasogastric (standard) ‐ 5 male, 7 female
DISEASE STATUS 
 Nephroblastoma
 Rhabdomyosarcoma
 Ewing sarcoma
 Neuroblastoma
 Osteosarcoma
 Germ cell tumour
 Hepatoblastoma
 Brain tumour
Malnourished at diagnosis
CHEMOTHERAPY/RADIOTHERAPY 
 All patients received chemotherapy and/or radiotherapy
Interventions 27 patients randomly assigned:
 EN nasogastric (energy enriched) ‐ (n = 15), EN nasogastric (standard) ‐ (n = 12)
EN tube feeding was administered at home and during hospital admission via a small bore silicone duodenal feeding tube with a weighted tip that was inserted into the stomach. During hospital admissions, the tube feeding was administered by continuous infusion over a 24‐hour period. At home the feeding routine was flexible and tailored to individual needs. The total volume of tube feeding to be administered was set to provide each child with 100% of the total daily energy requirement for the standard formula and 150% of the total energy requirement for the energy enriched formula.
Outcomes Primary outcomes 
 Change in nutritional  indices
 ‐ Weight for height measurements weekly
 ‐ Mid‐upper arm circumference weekly
 ‐ Triceps skinfold weekly
 ‐ Biceps skinfold weekly
‐ Calculated muscle (arm area)
 ‐ Serum albumin at diagnosis, at initiation of tube feeding and weekly thereafter
 ‐ Pre‐albumin at diagnosis, at initiation of tube feeding and weekly thereafter
Adverse events
 ‐ Occurrence of vomiting (mean number of days per week on which vomiting occurred)
Calorie and nutritional intake
 ‐ Mean daily energy intake per week
‐ Mean daily total protein intake
Secondary outcomes 
 ‐ Patient tolerance/adherence with feeding
Notes The study period started at the initiation of tube feeding (week 0) and ended after 10 weeks
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: random generation unclear, but undertaken in pairs (block randomisation) before study
Allocation concealment (selection bias) Unclear risk Comment: not stated how undertaken
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Comment: not clear if formulas were unlabelled or concealed in any way so as researchers or participants were blinded. However it does state in the tube feed regimen description in the methods that it was unknown whether the child received the standard or energy dense formula, as volume of feed was calculated on the assumption that all patients received the standard feed.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: not clear if formulas were unlabelled or concealed in any way so as researchers or participants were blinded
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: many outcomes were measured from patient diaries ‐ unclear how much missing data was present. Also, 27/29 patients were analysed; missing patients were presumed to have dropped out of the control group (15 patients analysed in intervention group). As missing data was not imputed, this is not intention to treat.
Selective reporting (reporting bias) Low risk Comment: all measurements stated were reported
Other bias Low risk Comment: no other risks of bias noted