NCT03224286

Brief Summary

This is a pilot study that provides the investigators with an opportunity to assess the application of PSM technology for patient monitoring in the NICU. This is a prospective, observational, cohort study.The investigators expect the duration of infant participation in this study to be 6 hours per single recording session with no follow-up required.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

January 22, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
Last Updated

June 24, 2021

Status Verified

June 1, 2021

Enrollment Period

2.4 years

First QC Date

July 18, 2017

Last Update Submit

June 22, 2021

Conditions

ApneaRespiration Disorder

Keywords

Pressure sensitive mat

Outcome Measures

Primary Outcomes (1)

  • Accuracy of information collected from pressure sensitive mat.

    This study will examine the potential for incorporating PSM and video data analysis as part of an integrated patient monitoring environment.

    Six hours

Study Arms (7)

Incubator + <1500 g

Infants currently in an incubator with a weight of less than 1500 grams will be monitored while lying on a pressure sensitive mat.

Device: Pressure sensitive mat

Incubator + 1500 - 2500 g

Infants currently in an incubator with a weight between 1500 - 2500 grams will be monitored while lying on a pressure sensitive mat.

Device: Pressure sensitive mat

Overhead warmer + <1500 g

Infants currently in an overhead warmer with a weight less than 1500 grams will be monitored while lying on a pressure sensitive mat.

Device: Pressure sensitive mat

Overhead warmer + 1500 - 2500 g

Infants currently in an overhead warmer with a weight between 1500 - 2500 grams will be monitored while lying on a pressure sensitive mat.

Device: Pressure sensitive mat

Overhead warmer + >2500 g

Infants currently in an overhead warmer with a weight over 2500 grams will be monitored while lying on a pressure sensitive mat.

Device: Pressure sensitive mat

Crib + 1500 - 2500 g

Infants currently in a crib with a weight between 1500 - 2500 grams will be monitored while lying on a pressure sensitive mat.

Device: Pressure sensitive mat

Crib + >2500 g

Infants currently in a crib with a weight over 2500 grams will be monitored while lying on a pressure sensitive mat.

Device: Pressure sensitive mat

Interventions

Pressure sensitive matDEVICE

Infant placed on pressure sensitive mat and has physiological parameters recorded.

Crib + 1500 - 2500 gCrib + >2500 gIncubator + 1500 - 2500 gIncubator + <1500 gOverhead warmer + 1500 - 2500 gOverhead warmer + <1500 gOverhead warmer + >2500 g

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Infants in the NICU will be eligible if their parents speak English or French and can be approached for consent.

You may qualify if:

  • Infants in the NICU will be eligible if their parents speak English or French and can be approached for consent.

You may not qualify if:

  • Patients who are moribund, suspected of having a neuromuscular condition affecting their movement or who are receiving muscle relaxant medications will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

MeSH Terms

Conditions

ApneaRespiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • JoAnn Harrold, MD

    Children's Hospital of Eastern Ontario

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division Chief, Neonatology

Study Record Dates

First Submitted

July 18, 2017

First Posted

July 21, 2017

Study Start

January 22, 2018

Primary Completion

June 15, 2020

Study Completion

June 15, 2020

Last Updated

June 24, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)