NCT06972849

Caffeine Citrate to Improve Neonatal Outcomes.

BabyCCINO: Caffeine Citrate to Improve Neonatal Outcomes. A Neonatal Domain Within PLATIPUS.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,900 (estimated)
• Sponsor: University of Melbourne · Academic / Other
• Sex: All
• Age: 32 Weeks
• Healthy volunteers: Not accepted

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).

Detailed description

The BabyCCINO trial will compare the efficacy and safety of a higher, medium or lower-dose caffeine regimen in very preterm infants. It is a neonatal domain within the PLATIPUS adaptive platform trial (NCT06461429). Apnoea of prematurity, which causes repeated episodes of low oxygen saturation, affects virtually all extremely preterm infants born \<28 weeks' gestation and more than half of those born 28-31 weeks' gestation. Apnoeic events are associated with poorer neurodevelopmental outcomes in infancy. Some very preterm infants also require mechanical ventilation due to apnoea, with an associated risk of bronchopulmonary dysplasia (BPD), the chronic lung disease of prematurity diagnosed at 36 weeks' post-menstrual age (PMA). Caffeine is one of the most commonly prescribed drugs in neonatal medicine and reduces apnoea of prematurity. The largest trial of caffeine in very preterm infants, the Caffeine for Apnea of Prematurity (CAP) trial, found that caffeine improves important short-term respiratory outcomes and longer-term brain development compared with placebo. There is evidence from small clinical trials of more benefit from higher dose caffeine than that used in the CAP trial, however, potential side effects include jitteriness, tachycardia and feed intolerance. A higher rate of cerebellar haemorrhage was also reported in one small trial in infants who received a higher loading dose of 80 mg/kg, along with a trend to higher seizure burden however, a Cochrane review did not identify any adverse effects of higher-dose caffeine. BabyCCINO will compare three dosing regimens routinely prescribed in Australia and Aotearoa New Zealand and assess health outcomes for infants who receive these. Very preterm infants born \<32 weeks' gestation will be randomly assigned to receive either * 40mg/kg loading dose and 20mg/kg daily maintenance * 30 mg/kg loading dose and 15mg/kg daily maintenance, or * 20mg/kg loading dose and 10mg/kg daily maintenance. Health outcomes will be assessed using the PLATIPUS Ordinal Outcome Scale, at 42 weeks' postmenstrual age or discharge home, whichever is earliest.

Conditions

• Apnea of Prematurity

Interventions

Type	Name	Description
DRUG	Caffeine citrate	Clinically indicated for apnea of prematurity.

Timeline

• Start date: 2025-10-01
• Primary completion: 2029-12-01
• Completion: 2050-12-01
• First posted: 2025-05-15
• Last updated: 2025-05-15