Continuous Vital Sign Monitoring in Newborns
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|ClinicalTrials.gov Identifier: NCT04154618|
Recruitment Status : Recruiting
First Posted : November 6, 2019
Last Update Posted : July 13, 2020
|Condition or disease||Intervention/treatment|
|Newborn Complication||Device: Continuous wireless vital sign monitoring|
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.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Continuous Vital Sign Monitoring in Newborns|
|Actual Study Start Date :||February 18, 2020|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
- Device: Continuous wireless vital sign monitoring
Infants will receive wireless vital sign monitoring throughout their birth hospitalization.
- 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.
- Accuracy assessed by comparison to conventional vital sign measurements within a 2-minute window [ Time Frame: 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 [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154618
|Contact: Barry Weinberger, MD||718-470-3440||BWeinberger@northwell.edu|
|Contact: Debra C Potak, RN||516-838-6434||DPotak@northwell.edu|
|United States, New York|
|Cohen Children's Medical Center of New York||Recruiting|
|New Hyde Park, New York, United States, 11040|
|Contact: Debra C Potak, RN 516-838-6436 firstname.lastname@example.org|
|Contact: Barry Weinberger, MD 718 470-3440 email@example.com|
|Principal Investigator: Barry Weinberger, MD|
|Sub-Investigator: Robert I Koppel, MD|
|Phelps Hospital||Not yet recruiting|
|Sleepy Hollow, New York, United States, 10591|
|Contact: Mazen T Khalifeh, MD 914-269-1914 firstname.lastname@example.org|
|Sub-Investigator: Mazen T Khalifeh, MD|