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 |