Validity and Feasibility of Newborn Bed Monitoring Device - a Clinical Pilot Study

Anna Axelin

Status: Enrolling

Conditions: Validation

Study type: Observational

Funder types: Other

Identifiers

NCT06679127

VARHA/1994/13.02.01/2024

Details and patient eligibility

About

The aim of this clinical pilot study is to evaluate the validity, acceptability and usability of the newborn bed monitoring device among newborns, parents and healthcare professionals in hospital environment. The specific aims for the study are to:

1. validate the following infant parameters collected with the bed monitoring device: heart rate, breathing rate, movements.
2. evaluate the feasibility on detecting awake, REM and non-REM sleep stages
3. collect data on environmental factors from the infant sleep environment
4. explore how parents and healthcare professionals perceive the acceptability and usability of the bed monitoring device
5. describe the key requirements for the bed monitoring device to be implemented in the newborn care path

The participating newborns will be sleeping on the bed monitoring device for two hours and the measurements of the device will be compared with the reference device (golden standard). The acceptability and usability will be assessed by parents and healthcare professionals by fulfilling a questionnaire and participating in interviews.

Enrollment: 315 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for newborns:

• received informed consent from both parents/guardians
• newborn is treated in the Ward of families and newborns
• newborn is having normal health status without ongoing additional treatments. No exclusion criteria

Inclusion criteria for parents:

• being a parent of newborn participating in the study with bed monitoring device
• being able to participate in Finnish. No exclusion criteria

Inclusion criteria for healthcare professionals:

• being a healthcare professional working with newborns
• being able to participate in Finnish. No exclusion criteria

Trial design

315 participants in 3 patient groups

Newborn

Description:

Newborn is sleeping in the bed monitoring device for two hours

Parents

Description:

Parents of the newborns participating in the study.

Healthcare professionals

Description:

Healthcare professionals participating in newborn care.