Continuous Vital Sign Monitoring in Newborns

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

Detailed Description
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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.

Official Title
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Continuous Vital Sign Monitoring in Newborns

Conditions
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Newborn Complication

Intervention / Treatment
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* Device: Continuous wireless vital sign monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Hours
Maximum Age: 12 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Continuous wireless vital sign monitoring|Infants will receive wireless vital sign monitoring throughout their birth hospitalization.|

What is the study measuring?
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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 |