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