Ellen de Kort

119 Propofol for intubation in neonates 7 Other side effects occurred in 10 patients (11%), including myoclonus in 8 patients (9%), bronchospasm in 1 patient (1%), and vocal cord spasm in 1 patient (1%). A total of 15 patients (16%) died at a median of 12 days after inclusion in this trial (range 0-57 days). Twelve patients died >72 hours after inclusion in the trial. One patient died from sepsis within 24 hours, and two patients died from necrotizing enterocolitis between 24 and 48 hours after inclusion. None were judged as directly attributable to the propofol administration. The results of the logistic regression analysis (Table 3) showed that GA and PNA did not influence the effectiveness or safety of propofol. Table 3. Logistic regression analysis with different outcome variables: primary outcome, effective sedation, and hypotension OR 95% CI p-value Primary outcome Gestational age (weeks) 0.94 0.77 - 1.15 0.54 Birth weight < 10 th percentile (yes/no) 0.85 0.22 - 3.34 0.82 Male gender (yes/no) 1.72 0.46 - 6.40 0.42 Postnatal age (in hours) 1.00 0.99 - 1.00 0.69 Starting dose of propofol (mg/kg) 4.50 0.92 - 22.11 0.06 Effective sedation Gestational age (weeks) 1.00 0.80 - 1.23 0.98 Birth weight < 10 th percentile (yes/no) 1.07 0.27 - 4.27 0.93 Male gender (yes/no) 2.67 0.76 - 9.36 0.13 Postnatal age (in hours) 1.00 0.99 - 1.00 0.65 Starting dose of propofol (mg/kg) 57.04 7.58 - 429.49 <0.001 Hypotension Gestational age (weeks) 1.09 0.94 - 1.26 0.26 Birth weight < 10 th percentile (yes/no) 1.55 0.52 - 4.25 0.47 Male gender (yes/no) 0.94 0.36 - 2.45 0.90 Postnatal age (in hours) 1.00 0.99 - 1.00 0.45 Starting dose of propofol (mg/kg) 1.09 0.35 - 3.39 0.88 Cumulative dose of propofol (mg/kg) 0.74 0.48 - 1.14 0.18 Corrected by Firth’s method to reduce bias because of relatively small sample size.