Status:
COMPLETED
The Paediatric Refill Study (PRefill)
Lead Sponsor:
University of Nottingham
Conditions:
Septicaemia
Deformity of Spine
Eligibility:
All Genders
1-15 years
Brief Summary
2 recent national reports 'Why Children Die' and 'Are we there yet?'identified deficiencies in recognising and managing sick children. Key recommendations from both reviews included the development an...
Detailed Description
Following recruitment, patients will have two devices placed on their skin, one on a limb (e.g. forearm), and one on their chest. They will be fixed to the skin using medical adhesive tape. The device...
Eligibility Criteria
Inclusion
- Children \& Young Adults
- Patients aged 1 month to 15 years with parental or legal guardian written informed consent.
- Patients groups:
- Patients who require PICU or high dependency care
- Matched controls who are well (PEWS\<3)
- Must have a realistic prospect of survival
- Parents/carers (for the interview element of the study):
- Parents/carers of children recruited into the PRefill study
- Healthcare professionals (for the interview element of the study):
- Healthcare professionals who have cared for a child with the device on
Exclusion
- Children \& Young Adults
- Known pregnancy
- Underlying cardiac anomaly likely to affect perfusion,
- PEWS ≥3 (in matched well controls)
- Severe eczema/burns/other skin condition on site where CRT device needs to be positioned
- Known allergy to medical adhesive
- Parents/carers (for the interview element of the study):
- Unable to communicate despite translation services
- Healthcare professionals (for the interview element of the study)
- None
Key Trial Info
Start Date :
August 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT02208817
Start Date
August 1 2014
End Date
May 1 2016
Last Update
May 19 2016
Active Locations (1)
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1
Nottingham Univeristy Hospitals NHS Trust
Nottingham, Nottinghamshire, United Kingdom, NG72UH