Clinical Trial

Caffeine Citrate to Improve Neonatal Outcomes.

Study acronym: BabyCCINO
Not Yet Recruiting
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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).
Trial Details
NCT Number NCT06972849
Lead Sponsor University of Melbourne
Conditions Apnea of Prematurity
Enrollment 3,900 participants
Start Date 2025-10
Primary Completion 2029-12 (estimated)
Study Completion 2050-12 (estimated)
Updated on ClinicalTrials.gov 2025-05-15