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Continuous Vital Sign Monitoring in Newborns

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04154618
Recruitment Status : Not yet recruiting
First Posted : November 6, 2019
Last Update Posted : November 6, 2019
Sponsor:
Collaborator:
New York State Department of Health
Information provided by (Responsible Party):
Barry Weinberger, Northwell Health

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

Condition or disease Intervention/treatment
Newborn Complication Device: Continuous wireless vital sign monitoring

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.


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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Continuous Vital Sign Monitoring in Newborns
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vital Signs


Intervention Details:
  • Device: Continuous wireless vital sign monitoring
    Infants will receive wireless vital sign monitoring throughout their birth hospitalization.


Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Healthy newborn infants < 12 hours of age admitted to the Well Baby Nursery
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

Information from the National Library of Medicine

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


Contacts
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Contact: Barry Weinberger, MD 718-470-3440 BWeinberger@northwell.edu
Contact: Debra C Potak, RN 516-838-6434 DPotak@northwell.edu

Locations
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United States, New York
Cohen Children's Medical Center of New York
New Hyde Park, New York, United States, 11040
Phelps Hospital
Sleepy Hollow, New York, United States, 10591
Sponsors and Collaborators
Northwell Health
New York State Department of Health

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Responsible Party: Barry Weinberger, Principal Investigator, Northwell Health
ClinicalTrials.gov Identifier: NCT04154618     History of Changes
Other Study ID Numbers: 19-0653
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All individual participant data (IPD).
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data will become available after enrollment is complete and all data have been collected
Access Criteria: Requests to the principal investigator (PI) to obtain data outlining the purpose of the study, the data elements to be accessed, preferred method of transmission, and preferred file type. For requests of identifiable information or information utilizing a limited data set a copy of valid institutional review board (IRB) approval and informed consent, as applicable. The PI will evaluate the request and ensure that appropriate regulatory approvals have been obtained. Once approved the investigator will be informed and relevant data transferred for analysis.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No