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

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.

Conditions

• Preterm Birth

Interventions

DRUG

Erythromycin

Antibiotic. Standard of care. Antibiotics will be administered for 7 days or until delivery (whichever is sooner).

DRUG

Amoxicillin and Erythromycin

Antibiotic. Antibiotics will be administered for 7 days or until delivery (whichever is sooner).

DRUG

Azithromycin

Antibiotic. Antibiotics will be administered for 7 days or until delivery (whichever is sooner).

DRUG

Caffeine citrate 20 mg/kg load and 10 mg/kg daily maintenance.

Lower dose caffeine: 20mg/kg load and 10mg/kg/day maintenance. Standard of care. Caffeine will be administered until at least 34+0 weeks' post-menstrual age, with the aim to cease caffeine by 36+0 weeks' post-menstrual age. Caffeine use beyond 36+0 weeks' post-menstrual age will be open-label.

DRUG

Caffeine citrate 30 mg/kg load and 15 mg/kg daily maintenance.

Medium dose caffeine: 30mg/kg load and 15 mg/kg/day maintenance. Caffeine will be administered until at least 34+0 weeks' post-menstrual age, with the aim to cease caffeine by 36+0 weeks' post-menstrual age. Caffeine use beyond 36+0 weeks' post-menstrual age will be open-label.

DRUG

Caffeine citrate 40 mg/kg load and 20 mg/kg daily maintenance

Higher dose caffeine: 40mg/kg load and 20mg/kg/day maintenance. Caffeine will be administered until at least 34+0 weeks' post-menstrual age, with the aim to cease caffeine by 36+0 weeks' post-menstrual age. Caffeine use beyond 36+0 weeks' post-menstrual age will be open-label.

Sponsors & Collaborators

• University of Auckland, New Zealand

  collaborator OTHER

• Monash University

  collaborator OTHER

• The University of Western Australia

  collaborator OTHER

• La Trobe University

  collaborator OTHER

• The University of New South Wales

  collaborator OTHER

• University of Tasmania

  collaborator OTHER

• Menzies School of Health Research

  collaborator OTHER

• University of Adelaide

  collaborator OTHER

• University of Sydney

  collaborator OTHER

• Mater Medical Research Institute

  collaborator OTHER

• University of Melbourne

  lead OTHER

Principal Investigators

• Clare Whitehead, MBChB, PhD · University of Melbourne, Royal Women's Hospital, Melbourne.

• Brett Manley, MBBS, PhD · University of Melbourne, Royal Women's Hospital, Melbourne

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-01

Primary Completion

2050-12-31

Completion

2050-12-31