Baby-CINO: CaffeINe Treatment Optimisation in Premature Infants

NCT06416956 | Unknown

• 2 other identifiers: PID1716123/SC/0397
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant,Premature; Caffeine

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Heart rate

  From baseline to two days later

• Oxygen saturation

  From baseline to two days later

Study Arms (1)

Preterm infant

Preterm infants receiving caffeine (prescribed clinically) will be studied

Drug: Caffeine

Interventions

Caffeine DRUG

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.

Preterm infant

Eligibility Criteria

• Age: Up to 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All participants will be inpatients on the Newborn Care Unit and born prematurely (before 37 weeks gestation)

You may qualify if:

• 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

You may not qualify if:

• Known chromosomal abnormality or life-threatening congenital abnormality
• Severe hypoxic insult at birth
• Intraventricular haemorrhage grade III or IV or other severe neurological pathology

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Newborn Care Unit, John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Premature Birth

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Caroline Hartley

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Hartley

CONTACT

+44 1865 234537; caroline.hartley@paediatrics.ox.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: May 16, 2024
• Study Start: December 11, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: May 16, 2024

Record last verified: 2023-12

Locations

GB (1)