Optimizing caffeine treatment in premature infants
Baby-CINO: CaffeINe Treatment Optimisation in Premature Infants
This study is testing how changing or stopping caffeine treatment affects the brain and breathing of premature babies to help improve their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | N/A to 37 Weeks |
| Sex | All |
| Sponsor | University of Oxford Academic / other |
| Locations | 1 site (Oxford, Oxfordshire) |
| Trial ID | NCT06416956 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of changing or stopping caffeine treatment on brain activity and breathing in premature infants. It involves monitoring brain activity before and two days after any changes in caffeine dosage, alongside tracking vital signs such as breathing rate, heart rate, and oxygen saturation for up to two weeks. The research aims to provide insights into how caffeine affects the health of premature babies during their clinical care.
Who should consider this trial
Good fit: Ideal candidates include premature infants born before 37 weeks' gestation who are receiving caffeine citrate and whose parents can provide informed consent.
Not a fit: Patients with known chromosomal abnormalities, severe congenital defects, or significant neurological issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved caffeine treatment protocols for premature infants, enhancing their health outcomes.
How similar studies have performed: While this approach is observational and specific, similar studies on caffeine treatment in premature infants have shown promising results in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Oxford, Oxfordshire
- Newborn Care Unit, John Radcliffe Hospital — Oxford, Oxfordshire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Caroline Hartley — University of Oxford
- Study coordinator: Caroline Hartley
- Email: caroline.hartley@paediatrics.ox.ac.uk
- Phone: +44 1865 234537
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.