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Updated: Oct 5, 2026
A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Association between age and outcomes of evidence-based feeding protocol versus usual care in critically ill patients:
Qiuhui Wang1, Jin Ke1, Yizhe Chen1
1Department of Critical Care Medicine, The Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi Medical Center, Nanjing Medical University, No. 299 Qingyang Road, Wuxi, 214023, China.
Background:
Nutrition therapy is essential in critically ill patients, yet large randomised trials have shown inconsistent results regarding the effect of an evidence-based feeding protocol. The NEED trial showed a feeding protocol could effectively promote delivery of enteral nutrition (EN) but did not reduce mortality. Age-related physiological differences may modify responses to nutritional therapy. This post hoc analysis of the NEED trial evaluated whether age modifies the association between implementation of an evidence-based feeding protocol and clinical outcomes among critically ill patients.
Methods:
This secondary analysis used data from the multicentre cluster-randomised NEED trial conducted across intensive care units (ICUs) in China. Adult patients newly admitted to participating ICUs were assigned to active implementation of a feeding protocol or usual care. Age was analyzed as both a continuous variable and predefined categories (≤65, 66-75, and ≥76 years). The primary effect-modification analysis evaluated the treatment-age interaction for 28-day all-cause mortality. Secondary outcome analyses, including organ failure (OF), persistent multiple OF, ICU length of stay, ICU-free days, infection within 7 days, and feeding intolerance, were exploratory. Mixed-effects Cox and logistic regression models were used to assess treatment effects and age-treatment interactions.
Results:
Among 2672 patients included in the analysis (median age 62 years [IQR 49-74]; 1798 [67.3%] male), the effect of evidence-based feeding protocol on 28-day mortality varied with age. Treatment benefit attenuated progressively with increasing age, with each 10-year increase associated with a higher adjusted hazard ratio (HR) for mortality (1.28; 95% CI 1.13-1.46; continuous interaction P < 0.001). In age-stratified analyses, the intervention reduced mortality in patients aged ≤65 years (adjusted HR 0.64; 95% CI 0.44-0.92) but not in those aged 66-75 years (adjusted HR 1.01; 95% CI 0.64-1.60) or ≥76 years (adjusted HR 1.29; 95% CI 0.89-1.88; categorical interaction P = 0.010). An exploratory analysis showed a similar age-dependent pattern for persistent multiple OF (interaction P = 0.017). Results were consistent in per-protocol and sensitivity analyses.
Conclusions:
In this secondary analysis, associations between an evidence-based feeding protocol and clinical outcomes differed across age groups. These exploratory and hypothesis-generating findings suggest potential age-related heterogeneity in treatment response, which requires confirmation in future prospective studies. Research registration unique identifying number (UIN) of the original NEED trial: ISRCTN Registry, Registry number: ISRCTN 12233792, registered on November 24, 2017.
