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

ConditionPreterm Birth

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorUniversity of Melbourne

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Pregnant and at risk of preterm birth

Receiving care at a participating site at the time of eligibility assessment.

Meets the eligibility criteria for at least one domain.

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

100,000 Participants

are divided into 2 treatment groups

Group A: Pregnancy Domain 01 - PROMOAT: Preterm Rupture Of Membranes Optimal Antibiotics TrialExperimental treatment 3 interventions

Group B: Neonatal Domain 01 - BabyCCINO: Caffeine Citrate to Improve Neonatal OutcomesExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

Number of participants who progress by at least one level higher on the PLATIPUS Ordinal Outcome Scale

The PLATIPUS-Ordinal Outcome Scale ranks the most severe core short-term infant health outcome in the specified time frame. Levels 1-15: 1= Well, liveborn infant; 2= Neonatal unit admission for \<48 hours; 3= Neonatal unit admission for \>/= 48 hours; 4= Non-invasive respiratory support for ≥ 4 hours \& \< 5 days; 5= Non-invasive respiratory support \>/= 5 days; 6= Mechanical ventilation via endotracheal tube for ≥ 4 hours \& \<7 days; 7= Mechanical ventilation via endotracheal tube for \>/=7 days; 8= Moderate respiratory morbidity; 9=Necrotising enterocolitis AND/OR Sepsis; 10= Severe Respiratory Morbidity; 11= Major Surgery; 12= Brain Injury; 13= TWO of severe respiratory morbidity OR major surgery OR brain injury; 14= Severe respiratory morbidity \& major surgery \& brain injury; 15 = Death.

Time frame