Infant,PrematureBaby-CINONCT06416956
Baby-CINO: CaffeINe Treatment Optimisation in Premature Infants
An observational study of Infant,Premature and Caffeine, run by University of Oxford at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages Up to 37 weeks
- Conditions the study is for
- Infant,Premature, Caffeine
- What is being tested?
- Caffeine
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Dec 2023to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 37 weeks
- All sexes
- No healthy volunteers
- Child
Study population: All participants will be inpatients on the Newborn Care Unit and born prematurely (before 37 weeks gestation)
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Newborn Care Unit, John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU
Caroline Hartley, +44 1865 234537, caroline.hartley@paediatrics.ox.ac.uk
Caroline Hartley, PhD
About this study
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
- Being tested
- Caffeine
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Preterm infant | Preterm infants receiving caffeine (prescribed clinically) will be studied Receives: Drug: Caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiration
Change in respiratory dynamics between baseline (time at which caffeine dose is changed/treatment ends) and approximately 2 days later
Measured: 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
Measured: From baseline to two days later
Secondary outcomes (2)
Heart rate
Change in heart rate between baseline (time at which caffeine dose is changed/treatment ends) and approximately 2 days later
Measured: From baseline to two days later
Oxygen saturation
Change in oxygen saturation between baseline (time at which caffeine dose is changed/treatment ends) and approximately 2 days later
Measured: From baseline to two days later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start11 Dec 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant,PrematureStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline Hartley, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416956
- Sponsor's protocol ID
- PID17161
- Other IDs
- 23/SC/0397
- Acronym
- Baby-CINO
- Status last verified
- Dec 2023
- First submitted
- 15 Dec 2023
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baby-CINO: CaffeINe Treatment Optimisation in Premature Infants
- ClinicalTrials.gov ID
- NCT06416956
- Acronym / sponsor ID
- Baby-CINO / PID17161
- Conditions
- Infant,Premature, Caffeine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm infant | – | Drug: CaffeinePreterm infants receiving caffeine (prescribed clinically) will be studied |
Who may qualify
- Ages
- Up to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All participants will be inpatients on the Newborn Care Unit and born prematurely (before 37 weeks gestation)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Known chromosomal abnormality or life-threatening congenital abnormality
- Severe hypoxic insult at birth
- Intraventricular haemorrhage grade III or IV or other severe neurological pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CaffeineWe 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. | Drug | Preterm infant |
Primary outcome
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
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
2 secondary outcomes
Heart rate
Time frame: From baseline to two days later
Oxygen saturation
Time frame: From baseline to two days later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Hartley principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant,Premature and Caffeine, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline Hartley (+44 1865 234537, caroline.hartley@paediatrics.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiration (time frame: From baseline to two days later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.