Baby-CINO: CaffeINe Treatment Optimisation in Premature Infants

Recruiting

• Conditions: Infant,Premature; Caffeine
• Interventions: Drug: Caffeine

• Registration Number: NCT06416956
• Lead Sponsor: University of Oxford

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study Start: 2023-12-11
• Study First Submitted: 2023-12-15
• Study First Submitted QC: 2024-05-15
• Last Update Submitted: 2024-05-15
• Study First Posted: 2024-05-16
• Last Update Posted: 2024-05-16
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Preterm infant	Caffeine	Preterm infants receiving caffeine (prescribed clinically) will be studied

Primary Outcome Measures

Name	Time	Method
Brain activity	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	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 Outcome Measures

Name	Time	Method
Heart rate	From baseline to two days later	Change in heart rate between baseline (time at which caffeine dose is changed/treatment ends) and approximately 2 days later
Oxygen saturation	From baseline to two days later	Change in oxygen saturation between baseline (time at which caffeine dose is changed/treatment ends) and approximately 2 days later

Trial Locations

Locations (1)

Newborn Care Unit, John Radcliffe Hospital; 🇬🇧 Oxford, Oxfordshire, United Kingdom