Baby-CINO
Research type
Research Study
Full title
Baby-CINO: CaffeINe treatment Optimisation in premature infants
IRAS ID
332655
Contact name
Caroline Hartley
Contact email
Duration of Study in the UK
0 years, 9 months, 0 days
Research summary
Babies born prematurely can frequently experience periods where they stop breathing, known as apnoea. These events can be life threatening and may have long term effects on brain development, so it is essential to reduce the likelihood of occurrence. Caffeine citrate is given to babies born very prematurely as it can reduce apnoea. This treatment is usually given at a similar dose for all babies and is stopped when they reach approximately 34 weeks postmenstrual age. However, some babies experience apnoea after caffeine has been stopped (with some needing to restart treatment), and other babies may not need caffeine for as long as they receive it. Some babies also don’t receive enough caffeine during treatment, whilst others probably receive too much. The aims of this study are to determine effective measures to identify (1) when an infant should stop caffeine treatment and (2) what dose they require during caffeine treatment. As apnoea is related to the immaturity of a premature baby’s brain, the study will investigate brain activity and breathing, and the relationship between the two, and how they vary in individual babies as treatment is changed. For the first aim, a cohort of babies will be studied just before they stop caffeine treatment and again approximately two days afterwards. For the second aim, a cohort of babies will be studied before they change caffeine dose and again approximately two days after the dose has been changed (either increased or decreased). This will allow us to assess how brain activity and breathing changes with caffeine, and individual differences will be compared with outcome. Changes in dose and the decision to stop treatment will be made by the treating clinician – no changes in dose or the decision to stop treatment will be made as part of this research study.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
23/SC/0397
Date of REC Opinion
16 Nov 2023
REC opinion
Favourable Opinion