100,000
Participants
Start Date
November 1, 2025
Primary Completion Date
December 31, 2050
Study Completion Date
December 31, 2050
Erythromycin
Antibiotic. Standard of care. Antibiotics will be administered for 7 days or until delivery (whichever is sooner).
Amoxicillin and Erythromycin
Antibiotic. Antibiotics will be administered for 7 days or until delivery (whichever is sooner).
Azithromycin
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.
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.
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
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.
Collaborators (1)
University of Auckland, New Zealand
OTHER
Monash University
OTHER
The University of Western Australia
OTHER
La Trobe University
OTHER
The University of New South Wales
OTHER
University of Tasmania
OTHER
Menzies School of Health Research
OTHER
University of Adelaide
OTHER
University of Sydney
OTHER
Mater Medical Research Institute
OTHER
University of Melbourne
OTHER