Continuous Vital Sign Monitoring in Newborns
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Newborn Complication
- Sponsor
- Northwell Health
- Enrollment
- 1000
- Locations
- 2
- Primary Endpoint
- Assessment of feasibility by questionnaires to nurses and mothers using the using the Technology Acceptance Model (TAM).
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
This study evaluates the feasibility and usability of continuous wireless vital sign monitoring of well newborns during their birth hospitalization.
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.
Investigators
Barry Weinberger
Principal Investigator
Northwell Health
Eligibility Criteria
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
Outcomes
Primary Outcomes
Assessment of feasibility by questionnaires to nurses and mothers using the using the Technology Acceptance Model (TAM).
Time Frame: Up to 3 days
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.
Secondary Outcomes
- 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)