PLatform for Adaptive Trials In Perinatal UnitS - [Core Protocol]
ConditionPreterm Birth
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Melbourne
About this trial
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.
Eligibility criteria
Qualifiers
None
Disqualifiers
Pregnant and at risk of preterm birth
Receiving care at a participating site at the time of eligibility assessment.
Meets the eligibility criteria for at least one domain.
Circumstances where death (pregnant woman or person/fetal) is deemed to be imminent and inevitable. The treating team may however decide that providing an opportunity for the pregnant woman or person to participate would be in their and/or their fetus/infant's interest. OR
Trial design
Treatments tested in this trial
- Erythromycin
- Amoxicillin and Erythromycin
- Azithromycin
- Caffeine citrate 20 mg/kg load and 10 mg/kg daily maintenance.
- Caffeine citrate 30 mg/kg load and 15 mg/kg daily maintenance.
- Caffeine citrate 40 mg/kg load and 20 mg/kg daily maintenance
Treatment groups
100,000 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
University of Melbourne
Lead sponsor
University of Auckland, New Zealand
Collaborator
Monash University
Collaborator
The University of Western Australia
Collaborator
La Trobe University
Collaborator
The University of New South Wales
Collaborator
University of Tasmania
Collaborator
Menzies School of Health Research
Collaborator
University of Adelaide
Collaborator
University of Sydney
Collaborator
Mater Medical Research Institute
Collaborator
Source ClinicalTrials.gov