Caffeine Citrate to Improve Neonatal Outcomes.
ConditionApnea of Prematurity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 32
SponsorUniversity of Melbourne
About this trial
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).
Eligibility criteria
Qualifiers
Born before 37 weeks gestation
Receiving pregnancy care at a participating site (hospital) at the time of eligibility assessment and
Meet eligibility criteria for one or more platform domains.
Disqualifiers
(Parent) Inability to consent for their infant, unless a domain-level waiver of consent is deemed appropriate.
Perinatal death is deemed to be imminent and inevitable during the next 24 hours (at time of screening), including if neonatal intensive care is not being provided to the infant.
Very preterm infants born <32 weeks' gestation
<72 hours old
Trial design
Treatments tested in this trial
- Caffeine citrate
Treatment groups
3,900 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov