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

Launched by UNIVERSITY OF MELBOURNE · Jun 13, 2024

Keywords

ClinConnect Summary

The PLATIPUS trial is a research study designed to find better ways to care for pregnant women at risk of having premature babies and for the infants themselves. The main goal is to understand how different treatments and types of care can improve the health of both the mothers and their babies. The trial will look at two main areas: how the care given during pregnancy affects the baby’s health and how different treatments for preterm infants influence their well-being.

To participate in this trial, you must be either a pregnant person at risk of preterm birth or a preterm baby born before 37 weeks of pregnancy. You should also be receiving care at a hospital involved in the study. If you meet these criteria and agree to join, you'll be randomly assigned to one of the treatment groups. It’s important to know that your involvement helps researchers learn more about improving health outcomes for both mothers and their babies, which could lead to better care in the future.

Gender

ALL

Eligibility criteria

• • 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.