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Table 1 Baseline and clinical characteristics of randomised children by treatment group

From: Oral prednisolone for acute otitis media in children: a pilot, pragmatic, randomised, open-label, controlled study (OPAL study)

Characteristics Prednisolone (n = 31) Control (n = 31)
Baseline characteristics
Age (months) mean ± SD 60. 7 ± 32.2 73.2 ± 38.3
Sex—male (n; %) 15 (48) 18 (58)
Breastfeeding (n; %) 28 (90) 27 (87)
 Breastfeeding until at least the first 6 months of life (n; %) 20 (71) 19 (70)
Child day care attendance (n; %) 1 (3) 1 (3)
 Duration per week (h) mean ± SD 50 35
Pre-school or school attendance (n; %) 21 (68) 20 (64)
 Duration per week (hours) mean ± SD 4.9 ± 2.0 4.7 ± 2.0
Parental education (father)a
 Primary education (i.e. elementary school) 1 (3) 2 (6)
 Secondary education (i.e. middle and high school) 13 (42) 17 (55)
 Tertiary education (e.g. diploma, bachelor, masters) 16 (52) 11 (35)
Parental education (mother)a
 Primary education (i.e. elementary school) 0 (0) 2 (6)
 Secondary education (i.e. middle and high school) 12 (39) 17 (55)
 Tertiary education (e.g. diploma, bachelor, masters) 19 (61) 11 (35)
Pneumococcal vaccinations (n; %) 9 (29) 7 (23)
Influenzae vaccinations (n; %) 6 (19) 7 (23)
≥ 3 episodes of acute respiratory infections in the past year (n; %) 23 (74) 22 (71)
First episode of AOM 20 (64) 21 (68)
 First episode of AOM at ≤ 2 years of age (n; %) 8 (26) 3 (10)
≥ 3 episodes of ear infection in the past year (n; %) 3 (10) 2 (6)
> 3 children in one house (n; %) 0 (0) 0 (0)
Passive smoking (n; %) 14 (45) 20 (64)
Ear discharge (n; %) 11 (35) 8 (26)
Concomitant diseases (n; %)
 Allergic rhinitis 3 (10) 2 (6)
 Bronchial asthma 0 (0) 1 (3)
 History of atopy in the family 12 (39) 9 (29)
AOM lateralisation—unilateral (n; %) 20 (64) 18 (58)
Clinical characteristics
Common cold 27 (87) 28 (90)
 Nose abnormalities (e.g. oedema, discharge) 23 (85) 23 (82)
 Tonsil abnormalities (e.g. hyperaemic, oedema) 15 (55) 15 (53)
 Throat abnormalities (e.g. hyperaemic, oedema) 15 (55) 8 (28)
Diagnosis of AOM
Confirmed by otoscope
 Hyperaemic tympanic membrane only 12 (39) 17 (55)
 Hyperaemic tympanic membrane and other signs of inflammation/middle ear effusionb 23 (74) 21 (68)
 Confirmed by otoscope and clarified by tympanometryc 25 (86) 25 (86)
Initial antibiotic given (n; %)
 Amoxicillin 4 (13) 11 (35)
 Amoxicillin/clavulanate 5 (16) 8 (26)
 Cefixime 12 (39) 3 (10)
 Cefadroxil 1 (3) 1 (3)
 Trimethoprim/sulfamethoxazole 0 (0) 1 (3)
 Clarithromycin 1 (3) 0 (0)
Other treatment given by doctors at initial visit (n; %)
 Acetaminophen 9 (29) 16 (52)
 Nonsteroidal anti-inflammatory drugs 4 (13) 5 (16)
 Decongestants and/or antihistamine 26 (84) 22 (71)
 Cough medicine 18 (58) 14 (45)
 Antibiotic ear drops 9 (29) 6 (19)
 Nasal (topical) decongestant 6 (19) 2 (6)
 Nasal corticosteroid 0 (0) 1 (3)
 Vitamins or herbals 3 (10) 8 (26)
 Ear diathermy 0 (0) 1 (3)
 Inhalation 0 (0) 1 (3)
 Others (e.g. mefenamic acid, nasal douching) 3 (10) 5 (16)
Tympanometry test (n; %) 29 (93) 29 (93)
 Complete 15 (52) 18 (62)
 Partial completion 0 (0) 6 (21)
 Sufficient values for analysis 15 (52) 22 (76)
 Type A 4 (27) 6 (27)
 Type C1 2 (13) 4 (18)
 Type C2 1 (7) 1 (4)
 Type B (or flat) 8 (53) 11 (50)
  1. aWe could not obtain the information of father’s (n = 2) and the mother’s education level (n = 1)
  2. bA child with bilateral AOM may have two different otoscopic results (e.g. hyperaemic tympanic membrane only and hyperaemic tympanic membrane with other signs of inflammation/middle ear effusion)
  3. cFour patients did not undergo tympanometry examination due to severe pain, not recommended by physicians due severe bulging, uncooperative child and nurse forgot. Patients with tympanic membrane perforation were considered as confirmed by otoscope and tympanometry