PLatform for Adaptive Trials In Perinatal UnitS - [Core Protocol]

PLATIPUS is an adaptive platform trial aimed at improving the health of infants born preterm (before 37 weeks' gestation). PLATIPUS will compare how different treatments and care provided to pregnant women and people at risk of preterm birth and infants born preterm affect infant health. The main questions PLATIPUS aims to answer are: 1. What effect/s do different treatments/care provided to pregnant women and people at risk of preterm birth have on the health of their infants? (Pregnancy domains) 2. What effect/s do different treatments/care given to infants born preterm have on their health ? (Neonatal domains). This registration record relates to the PLATIPUS Core (or 'master') protocol which provides guidance for the overall running of the trial. Additional appendices will outline the aims, questions, treatments, and activities for each separate research question (domain). Each Domain-Specific Appendix will be registered separately on ClinicalTrials.gov and will link to this record.

NCT Number	NCT06461429
Lead Sponsor	University of Melbourne Collaborators: University of Auckland, New Zealand, Monash University, The University of Western Australia, La Trobe University, The University of New South Wales, University of Tasmania, Menzies School of Health Research, University of Adelaide, University of Sydney, Mater Medical Research Institute
Conditions	Preterm Birth
Enrollment	100,000 participants
Start Date	2025-11-01
Primary Completion	2050-12-31 (estimated)
Study Completion	2050-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-06-13