Continuous Vital Sign Monitoring in Newborns

Northwell Health

Status: Enrolling

Conditions: Newborn Complication

Treatments: Device: Continuous wireless vital sign monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT04154618

19-0653

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: Under 12 hours old

Volunteers: No Healthy Volunteers

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