148 / 208
Chapter 7
146
Supplementary Table 4.
Protocol for scoring of infections
1.
Data export
All patients receiving antimicrobial agents were identified by the data manager, who provided
an export of all patient numbers with all the information on antimicrobial agents given as well
as the duration of such treatment.
2.
Identification of patients with infections
The infectious disease specialists, who were blinded for treatment allocation, selected all
patients receiving antimicrobial agents for more than 48h, after excluding all patients who
received prophylaxis. Each patient who fulfilled the criteria for infection, as well as the type
of infection, was identified as such based on thorough review of the medical record
6
. Patients
for whom antimicrobials were initiated prior to PICU admission or within the first 48 hours of
admission while the criteria for infection were fulfilled, were labeled as“
having an infection upon
admission
”. When antimicrobial agents were initiated after randomization and beyond the first
48 hours in the PICU, and were given for more than 48 hours while the criteria for infection were
fulfilled, the patient was labeled as “
having a new infection
”
6
.
Supplementary Table 5.
Logistic regression and Cox proportional hazards analyses
OR or HR
unadjusted
(95% CI)
Late PN vs.
Early PN
P-value
unadjusted
OR or HR
adjusted*
(95% CI)
Late PN vs.
Early PN
P-value
adjusted
Primary Outcomes
Odds for New Infection
0.53 (0.39-0.71)
< 0.001 0.48 (0.35-0.66)
< 0.001
Likelihood of Earlier Live Discharge
from PICU
1.14 (1.02-1.27)
0.01
1.23 (1.11-1.37)
< 0.001
Safety Outcomes
Odds for Death
Within 8 days in PICU
0.91 (0.48-1.71)
0.76
0.73 (0.34-1.51)
0.39
During PICU Stay
0.89 (0.55-1.45)
0.64
0.73 (0.42-1.28)
0.27
During Hospital Stay
0.84 (0.53-1.32)
0.44
0.72 (0.43-1.19)
0.20
Within 90 days after enrollment
0.77 (0.49-1.19)
0.23
0.64 (0.39-1.05)
0.07
Secondary Efficacy Outcomes
Likelihood of Earlier Live Weaning
from Mechanical Ventilatory Support
1.11 (1.00-1.24)
0.04
1.19 (1.07-1.32)
0.001
Odds for Renal Replacement Therapy 0.69 (0.37-1.26)
0.23
0.49 (0.24- 0.96)
0.03
Likelihood of Earlier Live Discharge
from Index Hospital
1.14 (1.03-1.27)
0.01
1.19 (1.07-1.33)
0.001
Likelihood of Earlier Live Discharge
from Hospital (Index and Transferral
Hospital)
1.14 (1.02-1.27)
0.02
1.21 (1.08-1.34)
< 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
and
STRONGkids category
1