Ignite Creation Date:
2024-07-17 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06461429
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-05-02
Brief Title:
PLatform for Adaptive Trials In Perinatal UnitS - Core Protocol
Sponsor:
University of Melbourne
Organization:
University of Melbourne
Study Overview
Official Title:
Platform for Adaptive Trials in Perinatal Units Core Protocol
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLATIPUS
Brief 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 effects do different treatmentscare provided to pregnant women and people at risk of preterm birth have on the health of their infants Pregnancy domains
2 What effects do different treatmentscare 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 ClinicalTrialsgov and will link to this record
The main questions PLATIPUS aims to answer are
1 What effects do different treatmentscare provided to pregnant women and people at risk of preterm birth have on the health of their infants Pregnancy domains
2 What effects do different treatmentscare 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 ClinicalTrialsgov and will link to this record
Detailed Description:
PLATIPUS is a multi-domain multi-centre international adaptive platform trial and innovative approach to perinatal research
Preterm birth birth before 37 weeks gestation is a global issue More than 15 million babies 1 in 10 are born preterm each year Complications of preterm birth are the leading cause of death and disability among children under five years of age These contribute to increased risk of all-cause mortality and early death from cardiovascular disease diabetes and chronic lung disease in later life There is no single cause of or pathway to preterm birth Treatments during pregnancy aim to prevent or treat complications that can lead to preterm birth in pregnant women and people or reduce the impact of prematurity on neonatal outcomes Treatments in the neonatal period period shortly after birth aim to improve survival and reduce potential morbidities in the preterm infant
PLATIPUS will initially assess interventions given to pregnant women and people during pregnancy Participant Group 1 and to preterm infants Participant Group 2 in the first few days of life Participants will be randomly allocated to all relevant domains for which they are eligible and provide consent Using a trial-developed Ordinal Outcome Scale the effect of pregnancy andor neonatal interventions on neonatal outcome will be assessed at 42 weeks post-menstrual age OR at primary hospital discharge whichever occurs earliest Secondary outcomes will examine the effect of interventions on individual pregnancy andor neonatal endpoints and may be domain-specific All pregnancy domains will include a Maternal Outcome Set to assess maternal health and intervention safety
In contrast to conventional clinical trials PLATIPUS has been designed to examine multiple different treatment options at once within the same platform Both pregnant and neonatal participants will be randomly assigned to different concurrent treatment options with an initial focus on treatments already considered as part of clinical care As the trial advances novel interventions may also be included Interventions will be evaluated within domains A domain is defined as a set of interventions that are intended for a specific health problem or specific therapeutic option
Bayesian adaptive statistical modelling will be used to evaluate treatment efficacy at regular interim adaptive analyses of the pre-specified outcomes for each intervention in each domain This will allow determination of the effectiveness of interventions once sufficient data has been accrued rather than when a pre-specified sample size is reached Adaptive analyses will compute the posterior probabilities of superiority futility inferiority or equivalence for pre-specified comparisons within domains Each of these potential conclusions will be pre-defined prior to commencing the intervention domain Decisions about trial results eg concluding superiority or equivalence will be based on pre-specified threshold values for posterior probability
All trial procedures are outlined in the core protocol described in this registration Separate domain protocols with information specific to each intervention included in PLATIPUS will be linked to this registration at separate clinicaltrialsgov records
Preterm birth birth before 37 weeks gestation is a global issue More than 15 million babies 1 in 10 are born preterm each year Complications of preterm birth are the leading cause of death and disability among children under five years of age These contribute to increased risk of all-cause mortality and early death from cardiovascular disease diabetes and chronic lung disease in later life There is no single cause of or pathway to preterm birth Treatments during pregnancy aim to prevent or treat complications that can lead to preterm birth in pregnant women and people or reduce the impact of prematurity on neonatal outcomes Treatments in the neonatal period period shortly after birth aim to improve survival and reduce potential morbidities in the preterm infant
PLATIPUS will initially assess interventions given to pregnant women and people during pregnancy Participant Group 1 and to preterm infants Participant Group 2 in the first few days of life Participants will be randomly allocated to all relevant domains for which they are eligible and provide consent Using a trial-developed Ordinal Outcome Scale the effect of pregnancy andor neonatal interventions on neonatal outcome will be assessed at 42 weeks post-menstrual age OR at primary hospital discharge whichever occurs earliest Secondary outcomes will examine the effect of interventions on individual pregnancy andor neonatal endpoints and may be domain-specific All pregnancy domains will include a Maternal Outcome Set to assess maternal health and intervention safety
In contrast to conventional clinical trials PLATIPUS has been designed to examine multiple different treatment options at once within the same platform Both pregnant and neonatal participants will be randomly assigned to different concurrent treatment options with an initial focus on treatments already considered as part of clinical care As the trial advances novel interventions may also be included Interventions will be evaluated within domains A domain is defined as a set of interventions that are intended for a specific health problem or specific therapeutic option
Bayesian adaptive statistical modelling will be used to evaluate treatment efficacy at regular interim adaptive analyses of the pre-specified outcomes for each intervention in each domain This will allow determination of the effectiveness of interventions once sufficient data has been accrued rather than when a pre-specified sample size is reached Adaptive analyses will compute the posterior probabilities of superiority futility inferiority or equivalence for pre-specified comparisons within domains Each of these potential conclusions will be pre-defined prior to commencing the intervention domain Decisions about trial results eg concluding superiority or equivalence will be based on pre-specified threshold values for posterior probability
All trial procedures are outlined in the core protocol described in this registration Separate domain protocols with information specific to each intervention included in PLATIPUS will be linked to this registration at separate clinicaltrialsgov records
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None