Neonatal Wireless Monitoring System for Intensive Care

NCT04241263 | Unknown

• 1 other identifier: A095011
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Preterm Infant; Infant, Newborn; Low; Birthweight, Extremely (999 Grams or Less)

Keywords

Patient monitoring; Medical device; Wireless

Outcome Measures

Primary Outcomes (1)

• Mean (SD) difference in ECG waveform data

  comparison of data between wired (standard care) and wireless system

  Up to 24 hours of monitoring data per participant

Secondary Outcomes (2)

• Impact on care: qualitative interviews with parents and staff

  immediately post intervention

• Impact on care: qualitative questionnaire with parents and staff

  immediately post intervention

Study Arms (2)

Comparative assessment of data quality

OTHER

Quantitative comparison between the current wired system and the new wireless system

Device: Wireless vital sign monitoring - comparative

Usability

OTHER

Qualitative assessment of the new wireless system

Device: Wireless vital sign monitoring - usability

Interventions

Wireless vital sign monitoring - comparative DEVICE

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.

Comparative assessment of data quality

Wireless vital sign monitoring - usability DEVICE

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).

Usability

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead
• University of Cambridge: collaborator

Study Sites (1)

Cambridge University Hospitals NHS Foundation Trust

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Premature Birth; Birth Weight

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• kathryn beardsall

  University of Cambridge

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathryn Beardsall, MRCP

CONTACT

01223746791; kb274@cam.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: 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
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Lecturer, Consultant Neonatologist

Study Record Dates

• First Submitted: January 12, 2020
• First Posted: January 27, 2020
• Study Start: March 1, 2020
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: January 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)