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| ID | Type | Description | Link |
|---|---|---|---|
| 23/SC/0397 | Other Identifier | Research Ethics Committee |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preterm infant | Preterm infants receiving caffeine (prescribed clinically) will be studied |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate | 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 | Change in oxygen saturation between baseline (time at which caffeine dose is changed/treatment ends) and approximately 2 days later |
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Inclusion Criteria:
Exclusion Criteria:
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All participants will be inpatients on the Newborn Care Unit and born prematurely (before 37 weeks gestation)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline Hartley | Contact | +44 1865 234537 | caroline.hartley@paediatrics.ox.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Caroline Hartley | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Newborn Care Unit, John Radcliffe Hospital | Recruiting | Oxford | Oxfordshire | OX3 9DU | United Kingdom |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D002110 | Caffeine |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
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|
| From baseline to two days later |
| D000091642 | Urogenital Diseases |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |