Proefschrift Kerklaan

PEPaNIC trial

Supplementary Table 6. P-values for interaction between randomized treatment allocation and the predefined baseline risk factors on the primary outcomes P-value

Patients with New Infections 1 PELOD score first 24h in PICU

0.80 0.55 0.25 0.11 0.72 0.80 0.65 0.73 0.19 0.56

Age group

Diagnostic group STRONGkids score 1

Center

Time to live discharge from the PICU 2 PELOD score first 24h in PICU

Age group

Diagnostic group STRONGkids score 1

Center

PELOD=PEdiatric Logistic Organ Dysfunction 7 , PICU=Pediatric Intensive Care Unit 1 Multivariable Logistic Regression Analysis censored at 90 days with non-survivors censored at 91 days 2 Multivariable Cox Proportional Hazard Analysis censored at 90 days with non-survivors censored at 91 days

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Supplementary Table 7. Adjusted Odds Ratios and Hazard Ratios further corrected for hypoglycemia (plasma concentration glucose < 40 mg/dL) and for the average amount of enteral feeding (kcal/kg/day) during randomisation window OR or HR adjusted* (95% CI) Late PN vs. Early PN (adjusted for hypoglycemia) P-value OR or HR adjusted* (95% CI) Late PN vs. Early PN (adjusted for enteral kcal/kg/d) P-value Primary Outcomes Patients with New Infections 0.45 (0.32-0.62) < 0.001 0.47 (0.34-0.65) < 0.001 Likelihood Earlier Live PICU Discharge 1.26 (1.13-1.41) < 0.001 1.24 (1.12-1.38) < 0.001

Secondary Efficacy Outcomes Likelihood Earlier Live Weaning from Mechanical Ventilatory Support

1.21 (1.09-1.35)

< 0.001 1.19 (1.07-1.32)

0.001

Renal-Replacement Therapy Likelihood Earlier Live Hospital Discharge

0.49 (0.24-0.97) 1.22 (1.09-1.36)

0.03

0.52 (0.25-1.03)

0.06

< 0.001 1.19 (1.07-1.33)

0.001

All duration of care outcomes were censored at 90 days with non-survivors censored at 91 days. OR=Odds Ratio, HR=Hazard Ratio, PN=Parenteral Nutrition, 95% CI= 95% Confidence Intervals, PICU=Pediatric Intensive Care Unit * Adjusted for the following risk factors: center, age group, diagnosis group, PELOD score first 24h 7 , STRONGkids category 1 and hypoglycemia (plasma concentration glucose < 40 mg/dL) or amount of enterally administered kcal per kg per day. In both analyses, experiencing hypoglycemia and receiving a higher amount of enterally administered kcal per kg per day were independent risk factors for infections and for a delayed live discharge from PICU (all P-values ≤0.004).

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