Table 3.
Clinical Outcomes By Enteral Nutrition Group
| Clinical Outcomes | Early EN (n = 331) | No Early EN (n = 277) | Estimate (95% CI)a | pb |
|---|---|---|---|---|
| 90-day hospital mortality, n (%) | 25 (8) | 46 (17) | OR = 0.43 (0.24–0.80) | 0.007 |
| 28-day hospital mortality, n (%) | 23 (7) | 35 (13) | OR = 0.56 (0.31–1.03) | 0.06 |
| ICU-free days (through Day 28), median (IQR) | 20.2 (9.1–23.7) | 17.2 (0–22.3) | HR = 1.26 (1.03–1.55) | 0.02 |
| Hospital-free days (through Day 28), median (IQR) | 8 (0–17) | 0 (0–12) | HR = 1.62 (1.18–2.23) | 0.003 |
| Ventilator-free days (through Day 28), median (IQR) | 21.4 (13.2–24.8) | 19.0 (3.0–23.2) | HR = 1.29 (1.07–1.57) | 0.009 |
| Maximum PELOD score (Day 2 through Day 28), median (IQR) | 11 (11–20) | 12 (11–22) | MD = −3.1 (−4.8 to −1.4) | <0.001 |
| Healthcare-associated infections, n (%) | 6 (2) | 10 (4) | OR = 0.47c (0.15–1.48) | 0.20c |
CI = confidence interval, EN = enteral nutrition, HR = hazard ratio, ICU = intensive care unit, IQR = interquartile range, MD = mean difference, OR = odds ratio, PELOD = pediatric logistic organ dysfunction.
OR < 1 indicates fewer events; HR > 1 indicates more ICU-free, hospital-free, and ventilator-free days; and MD < 0 indicates lower maximum PELOD scores for the early EN group compared to the no early EN group.
Effect estimates and p values comparing early EN and no early EN groups were calculated with the use of logistic, proportional hazards, or linear regression, as appropriate, adjusting for age category, BMI z-score category, mean vasopressor-inotrope score at randomization, primary reason for ICU admission, and PRISM-III score at 12 hours from ICU admission accounting for site as a cluster variable.
Unadjusted odds ratio and p value comparing early EN and no early EN groups were calculated with the use of univariate logistic regression accounting for site as a cluster variable due to low counts.