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NCT06461429

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

Sponsor: University of Melbourne

View on ClinicalTrials.gov

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.

Official title: Platform for Adaptive Trials in Perinatal Units (Core Protocol)

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

100000

Start Date

2025-11-01

Completion Date

2050-12-31

Last Updated

2025-06-13

Healthy Volunteers

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.

Potential participants with core platform eligibility AND who meet all domain-specific inclusion criteria and none of the domain-specific exclusion criteria for at least one PLATIPUS domain, will be eligible to 'enrol' in the PLATIPUS trial and randomised to all eligible domains, for which consent has been provided. CORE PLATFORM ELIGIBILITY - PREGNANCY DOMAINS Inclusion Criteria: Pregnant women and people must fulfil the following inclusion criteria to be eligible to participate in PLATIPUS: 1. Pregnant and at risk of preterm birth 2. Receiving care at a participating site at the time of eligibility assessment. 3. Meets the eligibility criteria for at least one domain. Exclusion Criteria: Pregnant women and people who meet the following criteria will be excluded from participation in this trial: 1. 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 2. Inability to consent, unless a waiver of consent has been deemed appropriate at domain-level. CORE PLATFORM ELIGIBILITY - NEONATAL DOMAINS Inclusion Criteria: Preterm infants must fulfil the following criteria to be eligible to participate in PLATIPUS, infants must be: 1. Born preterm (\<37 weeks' gestational age) 2. Receiving care at a participating site at the time of eligibility assessment. 3. Meet the eligibility criteria for at least one domain. Exclusion Criteria: Preterm infants who meet the following criteria will be excluded from participation in this trial: 1. Circumstances where death (neonatal) is deemed to be imminent and inevitable. The treating team may however decide that providing an opportunity for the infant to participate is in the infant's interest. OR 2. Parental/guardian inability to consent, unless a waiver of consent has been deemed appropriate at domain-level. DOMAIN-SPECIFIC ELIGIBILITY CRITERIA Potential participants who meet core platform eligibility criteria will be assessed for eligibility to participate in trial domains available at their hospital. Domain-specific eligibility criteria are outlined in the related Domain-Specific Appendices.

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria