PLATIPUS
Testing and transforming care
in pregnancy and preterm birth
Primary Outcome
Identifying better therapies and care strategies for pregnant people at risk of preterm birth and preterm infants, judged by an ordinal outcome scale that reflects neonatal health and wellbeing.
PLATIPUS is an innovative adaptive platform trial designed to rapidly evaluate multiple interventions—across both pregnancy and neonatal care—against a unified health scale, so we can more quickly discover what works best for preterm outcomes.(platipustrial.org)
Background
Preterm birth—before 37 weeks’ gestation—is the leading cause of death and disability in children under five.(ctv.veeva.com)
Traditional clinical trials typically study a single intervention in isolation, slowing progress as the evidence must be gathered one question at a time.(platipustrial.org)
PLATIPUS uses an adaptive platform design, running multiple “domains” concurrently—each testing different treatments in pregnant people or preterm infants—and continuously adapting based on data.(platipustrial.org)
Trial design
PLATIPUS is a multi-domain, multi-centre, international adaptive platform trial.(ctv.veeva.com)
Pregnancy domains test therapies in people at risk of preterm birth; Neonatal domains test interventions in infants born preterm.(platipustrial.org)
Participants are randomly assigned to all relevant domains for which they’re eligible and have provided consent.(ctv.veeva.com)
The trial uses a custom Ordinal Outcome Scale to assess neonatal health at either 42 weeks post‑menstrual age or hospital discharge—whichever comes first. Pregnancy domains also include maternal health safety measures.(ctv.veeva.com)
Interventions include antibiotic regimens in PPROM (e.g., amoxicillin + erythromycin, azithromycin; PROMOAT pregnancy domain) and varied caffeine citrate dosing for neonatal apnea prevention/treatment (BabyCCINO neonatal domain).(MedPath)
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.(ctv.veeva.com)
“My systematic thinking approach is focused on delivering platform solutions that improve process efficiencies for Spiral's clients and contribute to their trial's success.”
Spiral’s contribution
Our Spiral Product Owner for PLATIPUS is Gosia Costar
Gosia is the Product Owner at Spiral responsible for the PLATIPUS study, among others like T1D Plus and Mega‑ROX. She brings a systematic, solutions-focused approach to streamlining trial processes and ensuring success.
Key connections
Principal Investigators:
Prof. Brett Manley – Co-founder & Neonatologist
A/Prof. Clare Whitehead – Co-founder & Maternal–Fetal Medicine Specialist (X - The PLATIPUS Trial), (platipustrial.org)
Leadership Structure:
Trial Steering Committee (TSC) – Oversees trial design, conduct & reporting; includes expert clinicians, statisticians, and committee representatives (e.g., Pregnancy & Neonatal Domain Committees, Cultural Leadership, Lived Experience Committee).(platipustrial.org)
Trial Management Committee (TMC) – Handles daily trial operations; includes lead investigators, biostatisticians, data managers, and lived experience experts.(platipustrial.org)
Data Safety & Monitoring Committee (DSMC) – Monitors trial progress, safety, recruitment, data quality.(platipustrial.org)
Expert Advisory Panel (EAP) – Provides scientific guidance on domain prioritization, trial conduct, and dissemination.(platipustrial.org)
Statistics Advisory Committee – Oversees statistical methodology, especially Bayesian and adaptive-randomisation processes.(platipustrial.org)
Lived Experience Committee – Composed of individuals and parents with lived experience of preterm birth; involved in all trial stages.(platipustrial.org)
Cultural Leadership Committees – Indigenous-led groups guiding culturally safe trial design and implementation.(platipustrial.org)
