Baby-CINO: CaffeINe Treatment Optimisation in Premature Infants (Baby-CINO)

May 15, 2024 updated by: University of Oxford
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • Recruiting
        • Newborn Care Unit, John Radcliffe Hospital
        • Contact:
        • Principal Investigator:
          • Caroline Hartley, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Preterm infant
Preterm infants receiving caffeine (prescribed clinically) will be studied
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiration
Time Frame: 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
From baseline to two days later
Brain activity
Time Frame: 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
From baseline to two days later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: 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
From baseline to two days later
Oxygen saturation
Time Frame: 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
From baseline to two days later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Investigators

  • Principal Investigator: Caroline Hartley, University of Oxford

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

December 15, 2023

First Submitted That Met QC Criteria

May 15, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 15, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PID17161
  • 23/SC/0397 (Other Identifier: Research Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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