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

Sponsor
University of Melbourne
Study ID
NCT06461429
Status
Not Yet Recruiting

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Conditions

  • Preterm Birth

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Erythromycin — DRUG
    Antibiotic. Standard of care. Antibiotics will be administered for 7 days or until delivery (whichever is sooner).
  • Amoxicillin and Erythromycin — DRUG
    Antibiotic. Antibiotics will be administered for 7 days or until delivery (whichever is sooner).
  • Azithromycin — DRUG
    Antibiotic. Antibiotics will be administered for 7 days or until delivery (whichever is sooner).
  • Caffeine citrate 20 mg/kg load and 10 mg/kg daily maintenance. — DRUG
    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.
  • Caffeine citrate 30 mg/kg load and 15 mg/kg daily maintenance. — DRUG
    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.
  • Caffeine citrate 40 mg/kg load and 20 mg/kg daily maintenance — DRUG
    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.

Study Details

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.

Key Dates

First listed
Jun 17, 2024
Start date
Nov 1, 2025
Status verified
Jun 2024
Primary completion
Dec 31, 2050
Completion
Dec 31, 2050

Study Design

Enrollment
100,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pregnancy Domain 01 - PROMOAT: Preterm Rupture Of Membranes Optimal Antibiotics Trial
    ClinicalTrial.gov Trial Registration: NCT06906757. Population: Pregnant women and people with PPROM \<37 weeks' gestation and active neonatal management anticipated. Interventions: Randomised to receive routinely used broad-spectrum antibiotic prophylaxis
  • Experimental: Neonatal Domain 01 - BabyCCINO: Caffeine Citrate to Improve Neonatal Outcomes
    ClinicalTrial.gov Trial Registration: NCT06972849. Population: Very preterm infants born \<32 weeks' gestation, up to 10 days old, with any clinical indication to commence caffeine treatment (any of: prevention of apnoea, treatment of apnoea, or with the aim of improving longer-term outcomes. Interventions: Randomised to receive high, medium and low-dose caffeine citrate.

Primary Outcome Measure

Number of participants who progress by at least one level higher on the PLATIPUS Ordinal Outcome Scale [ Time Frame: At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier). ]

Central Contacts

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