Baby-CINO: CaffeINe Treatment Optimisation in Premature Infants

University of Oxford

Status: Enrolling

Conditions: Caffeine; Infant,Premature

Treatments: Drug: Caffeine

Study type: Observational

Funder types: Other

Identifiers

NCT06416956

23/SC/0397 (Other Identifier)

PID17161

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: Under 37 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Preterm infant

Description:

Preterm infants receiving caffeine (prescribed clinically) will be studied

Treatment:

Drug: Caffeine