PLATIPUS
Improving outcomes for babies born preterm
The PLATIPUS Trial
PLATIPUS is an innovative adaptive platform trial designed to assess medicines and therapies in pregnancies at risk of preterm birth (birth before 37 weeks gestation), and in babies born preterm: platipustrial.org
Primary Outcome:
Improved health outcomes for babies at risk of preterm birth, or born preterm, assessed using a ranked scale of health outcomes important to baby health and wellbeing.
Background
Preterm birth—before 37 weeks’ gestation—is the leading cause of death and disability in children under five
Traditional clinical trials typically study a single intervention in isolation, slowing progress as the evidence must be gathered one question at a time
PLATIPUS uses an adaptive platform design, running multiple “domains” concurrently—each assessing different medicines or therapies in pregnant people at risk of preterm birth, or infants born preterm—and continuously adapting based on dataAustralian mortality rates for heart attack range between 87-94%.
Trial design
Participants are randomly assigned to all domains for which they are eligible and have provided consent
The trial utilises a custom Ordinal Outcome Scale to assess neonatal health at either 42 weeks postmenstrual age or the first discharge home from the hospital — whichever comes first. Pregnancy domains also include maternal health and safety measures
PLATIPUS is a multi-domain, multi-centre, international adaptive platform trial
Pregnancy domains assess interventions in pregnant people at risk of preterm birth; Neonatal domains assess interventions in infants born preterm
The trial employs Bayesian adaptive methods: regularly performing interim analyses to determine whether treatments are superior, futile, inferior, or equivalent—with flexibility to drop or add interventions when sufficient data has been collected
“You hear of working in an agile environment but this really is as agile as it gets.”
Spiral’s contribution
Our Spiral Project Lead and EDC Product Owner for the PLATIPUS trial is Jess Green
In charge of overseeing software development that’s used in clinical trials, Jess not only engages clients but, like glue, she also pulls the team together along the path of delivery.