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Baby-CINO: CaffeINe Treatment Optimisation in Premature Infants

Baby-CINO: CaffeINe Treatment Optimisation in Premature Infants

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06416956
Acronym
Baby-CINO
Enrollment
30
Registered
2024-05-16
Start date
2023-12-11
Completion date
2024-09-01
Last updated
2024-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caffeine, Infant,Premature

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.

Interventions

DRUGCaffeine

We will record infant's brain activity and vital signs when caffeine dose is changed or caffeine treatment is stopped. The decision to change dose/stop treatment will be made by the clinical team as part of routine care. No changes in caffeine treatment will be carried out solely for research purposes.

Sponsors

University of Oxford
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 37 Weeks
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

Design outcomes

Primary

MeasureTime frameDescription
RespirationFrom baseline to two days laterChange in respiratory dynamics between baseline (time at which caffeine dose is changed/treatment ends) and approximately 2 days later
Brain activityFrom baseline to two days laterChange in EEG activity between baseline (time at which caffeine dose is changed/treatment ends) and approximately 2 days later

Secondary

MeasureTime frameDescription
Heart rateFrom baseline to two days laterChange in heart rate between baseline (time at which caffeine dose is changed/treatment ends) and approximately 2 days later
Oxygen saturationFrom baseline to two days laterChange in oxygen saturation between baseline (time at which caffeine dose is changed/treatment ends) and approximately 2 days later

Countries

United Kingdom

Contacts

Primary ContactCaroline Hartley
caroline.hartley@paediatrics.ox.ac.uk+44 1865 234537

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026