Table 2.
Characteristics of the 110 Trials Included in this Review, Stratified by Type of Journal
| Parameter | Pediatric Journals (n = 42) |
General Journals (n = 68) |
|---|---|---|
| Design | ||
| Parallel | 40 (95) | 68 (100) |
| Cross-Over | 2 (5) | 0 |
| Factorial Trial | 0 | 7 (10) |
| Cluster Trial | 3 (7) | 3 (4) |
| Noninferiority or Equivalence Trial | 4 (10) | 8 (12) |
| Centre† | ||
| Multicentre | 26 (62) | 58 (85) |
| Participants in more than one country | 8 (19) | 21 (30) |
| Funding | ||
| Pharma only | 10 (24) | 15 (22) |
| Pharma and Institutional | 3 (7) | 9 (13) |
| Institutional only | 24 (57) | 44 (65) |
| Unclear | 5 (12) | 0 |
| Participants† | ||
| Neonates | 23 (55) | 17 (25) |
| Infants/Toddlers (<24 m) | 11 (26) | 27 (40) |
| Child (2-11 y) | 14 (33) | 34 (50) |
| Adolescents (11-18 y) | 9 (24) | 35 (51) |
| Adults | 1 (2) | 28 (41) |
| Category of Main Disease* | ||
| Neonatal | 22 (52) | 9 (13) |
| Endocrine, nutritional and metabolic | 6 (14) | 3 (4) |
| Infections | 2 (5) | 16 (23) |
| Vaccine trials | 3 (7) | 14 (20) |
| Respiratory | 3 (7) | 7 (10) |
| Cancer | 0 | 5 (7) |
| Other | 6 (14) | 14 (21) |
| Setting | ||
| Outpatient | 16 (38) | 40 (59) |
| Inpatient | 5 (12) | 12 (18) |
| Intensive Care | 21 (50) | 16 (23) |
| Type of Interventions | ||
| Drug | 24 (57) | 56 (82) |
| Invasive | 6 (14) | 5 (7) |
| Other | 12 (29) | 7 (10) |
| Number of study groups | ||
| 2 arms | 38 (91) | 55 (81) |
| >2 arms | 4 (9) | 13 (19) |
| Use of Placebo or Sham arm | 18 (43) | 35 (52) |
| Duration of Intervention | ||
| Adequately reported | 36 (86) | 67 (97) |
| <1 month | 23/36 (64) | 35/67 (52) |
| 1-12 months | 11/36 (31) | 21/67 (31) |
| >12 months | 2/36 (5) | 11/67 (17) |
| Planned Power Calculation | 31 (74) | 61 (90) |
| Number of Participants | ||
| Median [IQR]# | 136 [50-400] | 601 [215-2360] |
| <50 | 11 (26) | 0 |
| 50-200 | 14 (33) | 15 (22) |
| 200-1000 | 9 (21) | 25 (37) |
| >1000 | 8 (19) | 28 (41) |
| Survival Outcome (primary or secondary) | 19 (45) | 37 (54) |
| Time to Primary Outcome | ||
| Adequately reported | 28 (67) | 57 (84) |
| <1 month | 15/28 (54) | 15/57 (26) |
| 1-12 months | 11/28 (39) | 28/57 (49) |
| >12 months | 2/28 (7) | 14/57 (25) |
| Recruitment Length | ||
| Adequately Reported | 35 (83) | 65 (96) |
| Median [IQR] months# | 30 [21-38] | 29 [22-48] |
N (%) unless otherwise stated
†Each category is coded separately, so total may either exceed or not add up to 100%.
*Adapted from the ICD-10 Disease Categories
#IQR: Inter Quartile Range