Continuous Vital Sign Monitoring in Newborns
1 other identifier
observational
1,000
1 country
2
Brief Summary
This study evaluates the feasibility and usability of continuous wireless vital sign monitoring of well newborns during their birth hospitalization.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2020
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2019
CompletedFirst Posted
Study publicly available on registry
November 6, 2019
CompletedStudy Start
First participant enrolled
February 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedApril 18, 2023
April 1, 2023
5.2 years
October 11, 2019
April 14, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Assessment of feasibility by questionnaires to nurses and mothers using the using the Technology Acceptance Model (TAM).
TAM questionnaires will be distributed to the nurse taking care of each subject at the time of discharge of the infant. The questionnaire will include informed consent by the nurse for participation in the research. A similar questionnaire will also be distributed to the mother just prior to discharge.
Up to 3 days
Secondary Outcomes (2)
Accuracy assessed by comparison to conventional vital sign measurements within a 2-minute window
Up to 3 days
Clinical Utility as measured by false alerts
Up to 3 days
Interventions
Infants will receive wireless vital sign monitoring throughout their birth hospitalization.
Eligibility Criteria
Healthy newborn infants \< 12 hours of age admitted to the Well Baby Nursery
You may qualify if:
- Healthy infants \<12 hours of age
- Expected to be admitted to the Well Baby Nursery
- or more weeks gestation at birth
- Mother at least 18 years of age
You may not qualify if:
- Infants requiring any non-routine medical care or observation
- Neonatal Intensive Care Unit (NICU) or Special Care Nursery admission
- Multiple birth
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwell Healthlead
- New York State Department of Healthcollaborator
Study Sites (2)
Cohen Children's Medical Center of New York
New Hyde Park, New York, 11040, United States
Phelps Hospital
Sleepy Hollow, New York, 10591, United States
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 11, 2019
First Posted
November 6, 2019
Study Start
February 18, 2020
Primary Completion
April 30, 2025
Study Completion
December 31, 2025
Last Updated
April 18, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR
- Time Frame
- Data will become available after enrollment is complete and all data have been collected
- Access Criteria
- Requests to the principal investigator (PI) to obtain data outlining the purpose of the study, the data elements to be accessed, preferred method of transmission, and preferred file type. For requests of identifiable information or information utilizing a limited data set a copy of valid institutional review board (IRB) approval and informed consent, as applicable. The PI will evaluate the request and ensure that appropriate regulatory approvals have been obtained. Once approved the investigator will be informed and relevant data transferred for analysis.
All individual participant data (IPD).