Neonatal Wireless Monitoring System for Intensive Care

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.

Conditions

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

Interventions

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.

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).

Sponsors & Collaborators

• University of Cambridge

  collaborator OTHER

• Cambridge University Hospitals NHS Foundation Trust

  lead OTHER

Principal Investigators

• kathryn beardsall · University of Cambridge

Study Design

Allocation

NON_RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

6 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-03-01

Primary Completion

2021-07-31

Completion

2021-07-31

Countries

• United Kingdom

Study Locations