Continuous Vital Sign Monitoring in Newborns

Newborn Complication Clinical Trial

Official title:

Continuous Vital Sign Monitoring in Newborns

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04154618
• Other study ID #: 19-0653
• Status: Recruiting
• Start date: February 18, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2023
• Source: Northwell Health
• Contact: Barry Weinberger, MD
• Phone: 718-470-3440
• Email: BWeinberger[@]northwell.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Hours to 12 Hours

Eligibility

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

Related Conditions & MeSH terms

• Newborn Complication

Intervention

Device:
• Continuous wireless vital sign monitoring
Infants will receive wireless vital sign monitoring throughout their birth hospitalization.

Locations

Country	Name	City	State
United States	Cohen Children's Medical Center of New York	New Hyde Park	New York
United States	Phelps Hospital	Sleepy Hollow	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	New York State Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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