A Multicenter, Parallel, Randomized, Double‐Blind, Placebo‐Controlled Trial with an Open‐Label Rescue Phase to Evaluate the Efficacy and Safety of Caffeine Citrate for Treatment of Apnea of Prematurity (AOP)
Latest Information Update: 19 Apr 2018
At a glance
- Drugs Caffeine citrate (Primary) ; Caffeine citrate (Primary)
- Indications Apnoea
- Focus Adverse reactions; Registrational; Therapeutic Use
- Sponsors Roxane Laboratories
Most Recent Events
- 19 Apr 2018 In this study (TGA document), 87 infants were randomized to two groups (46 were randomized to caffeine and 41 to placebo).Two patients did not receive drug and 3 were not included in the efficacy analysis because they had < 6 apnea episodes/24 hours at baseline.I have kept actual patient number as 87.
- 19 Apr 2018 New trial record