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Neonatal Wireless Monitoring System for Intensive Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04241263
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
University of Cambridge
Information provided by (Responsible Party):
Kathryn Beardsall, Cambridge University Hospitals NHS Foundation Trust

Brief Summary:

Babies who require intensive care need to have their heart rate, oxygen levels and temperature measured continuously using specially designed monitors. These monitors allow the clinical team to constantly assess the baby and see if they are becoming unwell. However, these monitors each have separate wires to connect them to the baby. Another important part of care in these babies is being able to allow parents to hold their babies, getting them out of their incubators to be cuddled. This is called Kangaroo care and has been shown to impact on long term health for both babies and parents.

We have designed a system to free babies of the wires that tether them to the monitors. This system has been tested in adults and we now want to test them on the babies.

There are two study parts with two different questions:

  1. How good is the data? This will compare the new wireless system with the existing system. Babies will have both standard wired monitors and the new wireless monitor on at the same time so we can compare the data to see how good is the quality of the data collected on the new system.
  2. What do parents and staff think about the wireless system during Kangaroo care? Babies who no longer need monitoring (but who previously had been monitored with the wired system), will have the wireless system attached and the parent will take their baby from the cot for Kangaroo Care. After the baby has been placed back in the cot, we will conduct interviews with the parent and the nurse to find out what they thought of the new system.

We hope this will help the investigators to understand about how good the data is we collect and how we might be able to improve the system.


Condition or disease Intervention/treatment Phase
Preterm Infant Infant, Newborn Low; Birthweight, Extremely (999 Grams or Less) Device: Wireless vital sign monitoring - comparative Device: Wireless vital sign monitoring - usability Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: This is a feasibility study but there are two arms and the babies, parents and staff will all be considered participants -it will be approximately 20 families recruited
Primary Purpose: Device Feasibility
Official Title: Feasibility Study of a Neonatal Wireless Transmission System (NeWTS)
Estimated Study Start Date : January 31, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 30, 2020

Arm Intervention/treatment
Comparative assessment of data quality
Quantitative comparison between the current wired system and the new wireless system
Device: Wireless vital sign monitoring - comparative
Participants who currently have vital sign monitoring will, in addition, have the wireless system attached. We will then collect up to 24 hours of vital sign data from both systems, which will allow us to make direct comparisons between them.

Usability
Qualitative assessment of the new wireless system
Device: Wireless vital sign monitoring - usability
Babies will be recruited who do not currently require vital sign monitoring. The wireless system will be attached to these babies by nurses who have been trained in its use. A parent will then be asked to perform Kangaroo Care for as long as they feel comfortable. After the baby is placed back in its cot, and the sensors have been removed, we will conduct (separate) interviews with the nurse and the parent on the neonatal intensive care unit (NICU).




Primary Outcome Measures :
  1. Mean (SD) difference in ECG waveform data [ Time Frame: Up to 24 hours of monitoring data per participant ]
    comparison of data between wired (standard care) and wireless system


Secondary Outcome Measures :
  1. Impact on care: qualitative interviews with parents and staff [ Time Frame: immediately post intervention ]
    Qualitative interviews

  2. Impact on care: qualitative questionnaire with parents and staff [ Time Frame: immediately post intervention ]
    Questionnaire



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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

(i) Babies being cared for on the NICU at Addenbrooke's Hospital (ii) Written, informed parental consent

Exclusion Criteria:

(i) Known to have an intolerance to silicone or silicone gel adhesives. (ii) Has a pacemaker, or other implanted electronic device


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241263


Contacts
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Contact: Kathryn Beardsall, MRCP 01223746791 kb274@cam.ac.uk

Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
University of Cambridge
Investigators
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Principal Investigator: kathryn beardsall University of Cambridge
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Responsible Party: Kathryn Beardsall, University Lecturer, Consultant Neonatologist, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04241263    
Other Study ID Numbers: A095011
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kathryn Beardsall, Cambridge University Hospitals NHS Foundation Trust:
Patient monitoring
Medical device
Wireless
Additional relevant MeSH terms:
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Birth Weight
Body Weight
Signs and Symptoms