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TABLE 1

Baseline Characteristics of Enrolled Infants

CharacteristicsPalivizumab (n = 210)Placebo (n = 210)
Age, mean (SD), d 46 (20) 49 (20) 
Boy/girl, n 123/87 127/83 
Birth wt, mean (SD), kg 3.2 (0.6) 3.2 (0.5) 
Gestational age at birth, mean (SD), wk 38.3 (1.3) 38.4 (1.4) 
Gestational age ≤34 wk, n (%) 3.0 (1.4) 2.0 (0.9) 
Past admission to the NICU, n (%) 11 (5.2) 13 (6.2) 
Patients presenting with upper respiratory symptoms, n (%) 210 (100) 209 (99.5) 
Duration of upper respiratory symptoms before enrollment, mean (SD), d 3.2 (1.8) 3.3 (1.7) 
Patients presenting with fever, n (%) 129 (61.4) 119 (56.7) 
Duration of fever before enrollment, mean (SD), d 1.1 (1.2) 1.0 (1.1) 
Patients presenting with cough, n (%) 209 (99.5) 209 (99.5) 
Duration of cough before enrollment, mean (SD), d 2.9 (2.0) 3.0 (1.6) 
Patients presenting with difficulty breathing, n (%) 167 (79.5) 179 (85.2) 
Duration of difficulty breathing before enrollment, mean (SD), d 1.4 (1.2) 1.4 (1.0) 
Baseline respiratory rate, mean (SD) 55.3 (8.6) 53.6 (9.6) 
Baseline heart rate, mean (SD) 164 (14.7) 164 (16.8) 
Baseline temperature, mean (SD), °C 37.8 (0.6) 37.8 (0.6) 
Baseline room air oxygen saturation, mean (SD) 97 (2) 97 (3) 
Palivizumab received previously, % 
Bronchiolitis severity score before enrollment, mean (SD) 5.5 (1.6) 5.3 (1.5) 
Positive pathogens other than RSV by PCR testing, n (%)   
 1 positive other than RSV 55 (26.2) 57 (27.1) 
 ≥2 positive other than RSV 12 (5.7) 13 (6.2) 
 Adenovirus 2 (1.0) 2 (1.0) 
 Bocavirus 2 (1.0) 2 (1.0) 
 Coronavirus 2 (1.0) 4 (1.9) 
 Human metapneumovirus 1 (0.5) 
 Influenza and/or parainfluenza virus 7 (3.3) 8 (3.8) 
 Rhinovirus 28 (13.3) 35 (16.7) 
 Parechovirus 14 (6.7) 6 (2.9) 
 Enterovirus 2 (1) 
Mycoplasma pneumoniae 1 (0.5) 1 (0.5) 
Chest plain radiograph, n (%)   
 Normal 153 (72.9) 149 (71.0) 
 Collapse or lobar consolidation 11 (5.2) 14 (6.7) 
 Lesser infiltrates 44 (21.0) 47 (22.4) 
Received antibiotic(s) during hospitalization, n (%) 56 (26.7) 54 (25.7) 
Patients who received PRN epinephrine nebulization, n (%) 12 (5.7) 12 (5.7) 
Patients who received PRN salbutamol nebulization, n (%) 11 (5.2) 12 (5.7) 
Patients who received corticosteroid during or after hospitalization 
CharacteristicsPalivizumab (n = 210)Placebo (n = 210)
Age, mean (SD), d 46 (20) 49 (20) 
Boy/girl, n 123/87 127/83 
Birth wt, mean (SD), kg 3.2 (0.6) 3.2 (0.5) 
Gestational age at birth, mean (SD), wk 38.3 (1.3) 38.4 (1.4) 
Gestational age ≤34 wk, n (%) 3.0 (1.4) 2.0 (0.9) 
Past admission to the NICU, n (%) 11 (5.2) 13 (6.2) 
Patients presenting with upper respiratory symptoms, n (%) 210 (100) 209 (99.5) 
Duration of upper respiratory symptoms before enrollment, mean (SD), d 3.2 (1.8) 3.3 (1.7) 
Patients presenting with fever, n (%) 129 (61.4) 119 (56.7) 
Duration of fever before enrollment, mean (SD), d 1.1 (1.2) 1.0 (1.1) 
Patients presenting with cough, n (%) 209 (99.5) 209 (99.5) 
Duration of cough before enrollment, mean (SD), d 2.9 (2.0) 3.0 (1.6) 
Patients presenting with difficulty breathing, n (%) 167 (79.5) 179 (85.2) 
Duration of difficulty breathing before enrollment, mean (SD), d 1.4 (1.2) 1.4 (1.0) 
Baseline respiratory rate, mean (SD) 55.3 (8.6) 53.6 (9.6) 
Baseline heart rate, mean (SD) 164 (14.7) 164 (16.8) 
Baseline temperature, mean (SD), °C 37.8 (0.6) 37.8 (0.6) 
Baseline room air oxygen saturation, mean (SD) 97 (2) 97 (3) 
Palivizumab received previously, % 
Bronchiolitis severity score before enrollment, mean (SD) 5.5 (1.6) 5.3 (1.5) 
Positive pathogens other than RSV by PCR testing, n (%)   
 1 positive other than RSV 55 (26.2) 57 (27.1) 
 ≥2 positive other than RSV 12 (5.7) 13 (6.2) 
 Adenovirus 2 (1.0) 2 (1.0) 
 Bocavirus 2 (1.0) 2 (1.0) 
 Coronavirus 2 (1.0) 4 (1.9) 
 Human metapneumovirus 1 (0.5) 
 Influenza and/or parainfluenza virus 7 (3.3) 8 (3.8) 
 Rhinovirus 28 (13.3) 35 (16.7) 
 Parechovirus 14 (6.7) 6 (2.9) 
 Enterovirus 2 (1) 
Mycoplasma pneumoniae 1 (0.5) 1 (0.5) 
Chest plain radiograph, n (%)   
 Normal 153 (72.9) 149 (71.0) 
 Collapse or lobar consolidation 11 (5.2) 14 (6.7) 
 Lesser infiltrates 44 (21.0) 47 (22.4) 
Received antibiotic(s) during hospitalization, n (%) 56 (26.7) 54 (25.7) 
Patients who received PRN epinephrine nebulization, n (%) 12 (5.7) 12 (5.7) 
Patients who received PRN salbutamol nebulization, n (%) 11 (5.2) 12 (5.7) 
Patients who received corticosteroid during or after hospitalization 

PRN, pro re nata (when necessary).

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