Table 2. Classification of the placebo–controlled drug trials in neonates in ClinicalTrials.gov (1999–2015) according to design and aim.
Strategy | Total | Curative Treatment | Disease Prevention |
---|---|---|---|
146 | 89 | 57 | |
Design | N = 146 | ||
Placebo versus drug parallel assignement | 105 | 58 | 47 |
Placebo versus drug trial as add-on therapy | 36 | 25 | 11 |
Factorial design | 3 | 3 | 0 |
Cross-over | 2 | 2 | 0 |
Aim | N = 146 | ||
Efficacy—Safety | 117 | 64 | 53 |
Efficacy with rescue treatment | 12 | 11 | 1 |
Pharmacokinetics | 17 | 15 | 2 |