Baby-CINO: CaffeINe Treatment Optimisation in Premature Infants
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Oxford
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Brain activity
Overview
Brief Summary
This study investigates how brain activity and breathing changes in premature babies when their dose of caffeine treatment is changed or stopped. The study will assess premature babies receiving caffeine treatment as part of their clinical care. Brain activity will be recorded just before caffeine dose is changed and again two days afterwards. Breathing and other 'vital signs' (breathing rate, heart rate, oxygen saturation) will be recorded from the baby's monitor between the recordings of brain activity and for up to two weeks afterwards.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 37 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Born to a mother aged 16 or over
- •Admitted to the Newborn Care Unit, John Radcliffe Hospital
- •Born prematurely (before 37 weeks' gestation)
- •Parent given informed written consent
- •Receiving caffeine citrate
Exclusion Criteria
- •Known chromosomal abnormality or life-threatening congenital abnormality
- •Severe hypoxic insult at birth
- •Intraventricular haemorrhage grade III or IV or other severe neurological pathology
Arms & Interventions
Preterm infant
Preterm infants receiving caffeine (prescribed clinically) will be studied
Intervention: Caffeine (Drug)
Outcomes
Primary Outcomes
Brain activity
Time Frame: From baseline to two days later
Change in EEG activity between baseline (time at which caffeine dose is changed/treatment ends) and approximately 2 days later
Respiration
Time Frame: From baseline to two days later
Change in respiratory dynamics between baseline (time at which caffeine dose is changed/treatment ends) and approximately 2 days later
Secondary Outcomes
- Heart rate(From baseline to two days later)
- Oxygen saturation(From baseline to two days later)