drugset
drugset / Trial / NCT06461429

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

NCT06461429 ↗

Not yet recruiting 100000 enrolled University of Melbourne La Trobe University · collabMater Medical Research Institute · collabMenzies School of Health Research · collabMonash University · collabThe University of New South Wales · collabThe University of Western Australia · collabUniversity of Adelaide · collabUniversity of Auckland, New Zealand · collabUniversity of Sydney · collabUniversity of Tasmania · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2025-11-01
Primary completion
2050-12-31
Completion
2050-12-31

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified — —
Subject Azithromycin Small molecule — —
Subject Caffeine Small molecule 10 mg/kg —
Subject Caffeine Small molecule 15 mg/kg —
Subject Caffeine Small molecule 20 mg/kg —
Subject Erythromycin Small molecule — —

Indications

No indication recorded.