Baby-CINO: CaffeINe Treatment Optimisation in Premature Infants

Caffeine Clinical Trial

— Baby-CINO  

Official title:

Baby-CINO: CaffeINe Treatment Optimisation in Premature Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06416956
• Other study ID #: PID17161
• Secondary ID: 23/SC/0397
• Status: Recruiting
• Start date: December 11, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: December 2023
• Source: University of Oxford
• Contact: Caroline Hartley
• Phone: +44 1865 234537
• Email: caroline.hartley[@]paediatrics.ox.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 37 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Caffeine
• Infant,Premature
• Premature Birth

Intervention

Drug:
• Caffeine
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.

Locations

Country	Name	City	State
United Kingdom	Newborn Care Unit, John Radcliffe Hospital	Oxford	Oxfordshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiration	Change in respiratory dynamics between baseline (time at which caffeine dose is changed/treatment ends) and approximately 2 days later	From baseline to two days later
Primary	Brain activity	Change in EEG activity between baseline (time at which caffeine dose is changed/treatment ends) and approximately 2 days later	From baseline to two days later
Secondary	Heart rate	Change in heart rate between baseline (time at which caffeine dose is changed/treatment ends) and approximately 2 days later	From baseline to two days later
Secondary	Oxygen saturation	Change in oxygen saturation between baseline (time at which caffeine dose is changed/treatment ends) and approximately 2 days later	From baseline to two days later