Comparing the different doses and regimens of caffeine given to very preterm infants with apnoea of prematurity (breathing problems).
Objective
To determine the optimal dose of caffeine citrate for very preterm infants experiencing apnoea of prematurity (breathing problems).
Who will be eligible?
Very preterm infants (babies born less than 32 weeks gestation) who meet the eligibility criteria and are receiving care at a hospital taking part in this trial.
Why is this important?
Apnoea of prematurity is when a baby born preterm stops breathing intermittently. It is common in preterm babies and occurs in almost all babies born at less than 28 weeks gestation.
Caffeine is routinely given to preterm babies who experience apnoea of prematurity. Caffeine has been shown to reduce both the number of times a baby stops breathing, and the number of babies who need additional help to breathe. This is important as it may also help to reduce the risk of other complications after birth and in the future.
Why are we doing this study?
The optimal dose of caffeine is unknown, and caffeine dosing practices vary in Australia, Aotearoa New Zealand and worldwide.
BabyCCINO will assess three common caffeine doses and dosing regimens that are given to babies born preterm, to reduce uncertainty and understand which dose is best for babies who experience apnoea of prematurity.
Funding: NHMRC GNT2043361; MRFF GNT2031127; Running for Premature Babies Grant
Ethics Reference: HREC/113477/RCHM-2024
Trial Registration: NCT06972849
Prof. Brett Manley
Chair, Professor, Neonatology
Assoc. Prof. Chris McKinlay
Neonatal Lead (NZ)
Dr Kate Hodgson
Neonatologist
Assoc. Prof. Clare Whitehead
Maternal and Fetal Medicine Specialist
Prof. Peter Davis
Professor, Neonatology
Prof. Jane Alsweiler
Professor, Neonatology
Dr. Elizabeth Baker
Neonatologist
Dr. Tugba Alarcon-Martinez
Neonatology trainee
Prof. Michael Stark
Neonatologist
Prof. Adrienne Gordon
Neonatologist
Dr. Elizabeth Oliphant
Lecturer, Pharmacy
Prof. Katherine Lee
Biostatistician
Dr Robert Mahar
Biostatistician
Ms. Jessica Berry
Lived Experience Consultant
Platform for Adaptive Trials in Perinatal Units