drugset / Trial / NCT06972849

Caffeine Citrate to Improve Neonatal Outcomes.

NCT06972849

Not yet recruiting 3900 enrolled University of Melbourne
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The goal of this clinical trial to learn what dose/s of caffeine citrate works to treat preterm born babies who have episodes where they stop breathing. It will also learn about the safety of different doses of caffeine citrate for the variety of preterm-born babies that are prescribed this. The main question it aims to answer is: Which dose is the optimal dose of caffeine citrate for very preterm babies to prevent short-term death and disease? Researchers will compare three different doses of caffeine citrate, which are already used in clinical practice to treat breathing stoppages in preterm babies, to see which dose works best. No placebo will be used. Participants will be given a 'loading' dose of caffeine citrate \<72 hours of life, and a smaller 'maintenance' dose once a day, for as long as the baby needs this. This trial will be undertaken as part of the PLATIPUS trial (NCT06461429).

Timeline

Start
2025-10
Primary completion
2029-12
Completion
2050-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Caffeine Small molecule 10 mg/kg Intravenous
Comparator Caffeine Small molecule 15 mg/kg Intravenous
Comparator Caffeine Small molecule 20 mg/kg Intravenous

Indications