Continuous Vital Sign Monitoring in Newborns

This study evaluates the feasibility and usability of continuous wireless vital sign monitoring of well newborns during their birth hospitalization.

Study Overview

• Status: Recruiting
• Conditions: Newborn Complication
• Intervention / Treatment: Device: Continuous wireless vital sign monitoring

Detailed Description

This study is conducted for the purposes of understanding the feasibility and acceptability of routine wireless continuous monitoring on healthy newborns as a standard practice & its effect on existing workflows and as a future tool for the early detection of undiagnosed problems. All infants will receive routine newborn nursing care .

Once alarm limits have been determined, the monitoring data will be analyzed in real time and out of range vital signs will alert the nurse to perform standard assessment of the newborn.

Nurse and parents will complete surveys regarding their experience with continuous vital sign monitoring.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• United States
  • New York
    • New Hyde Park, New York, United States, 11040
      • Recruiting
      • Cohen Children's Medical Center of New York
    • Sleepy Hollow, New York, United States, 10591
      • Not yet recruiting
      • Phelps Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 12 hours (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Healthy newborn infants < 12 hours of age admitted to the Well Baby Nursery

Description

Inclusion Criteria:

• Healthy infants <12 hours of age
• Expected to be admitted to the Well Baby Nursery
• 36 or more weeks gestation at birth
• Mother at least 18 years of age

Exclusion Criteria:

• Infants requiring any non-routine medical care or observation
• Neonatal Intensive Care Unit (NICU) or Special Care Nursery admission
• Multiple birth

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy assessed by comparison to conventional vital sign measurements within a 2-minute window	The mean continuous measurements within a 2-minute window around each conventional vital sign assessment (routinely, several in the first 4 hours after birth, and then every 12 hours) will be compared to the routine measurement.	Up to 3 days
Clinical Utility as measured by false alerts	Quantify false positive alerts and false negative alerts as a measure of potential adverse effect on nursing workflow and patient care	Up to 3 days

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: New York State Department of Health

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2020
• Primary Completion (Anticipated): April 30, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: October 11, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (Actual): November 6, 2019

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 19-0653

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All individual participant data (IPD).
• IPD Sharing Time Frame: Data will become available after enrollment is complete and all data have been collected
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No