Continuous Vital Sign Monitoring in Newborns
- Conditions
- Newborn Complication
- Registration Number
- NCT04154618
- Lead Sponsor
- Northwell Health
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- 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
- Infants requiring any non-routine medical care or observation
- Neonatal Intensive Care Unit (NICU) or Special Care Nursery admission
- Multiple birth
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of feasibility by questionnaires to nurses and mothers using the using the Technology Acceptance Model (TAM). 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 Outcome Measures
Name Time Method Accuracy assessed by comparison to conventional vital sign measurements within a 2-minute window Up to 3 days 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.
Clinical Utility as measured by false alerts Up to 3 days Quantify false positive alerts and false negative alerts as a measure of potential adverse effect on nursing workflow and patient care
Trial Locations
- Locations (2)
Cohen Children's Medical Center of New York
🇺🇸New Hyde Park, New York, United States
Phelps Hospital
🇺🇸Sleepy Hollow, New York, United States