Recruiting

Observational Study

Sponsor:

Northwell Health

Code:

NCT04154618

Conditions

Newborn Complication

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Continuous wireless vital sign monitoring

Study Details

Brief summary:

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

Conditions

Newborn Complication

Study ID

NCT04154618

Start date

Feb 18, 2020

Status verified date

Apr, 2023

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Apr 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Interventions

Continuous wireless vital sign monitoring

Infants will receive wireless vital sign monitoring throughout their birth hospitalization.

Primary outcome measure

  • Assessment of feasibility by questionnaires to nurses and mothers using the using the Technology Acceptance Model (TAM). [ Time Frame: Up to 3 days ]

Central Contacts and Locations

Central contacts

Barry Weinberger, MD

718-470-3440BWeinberger@northwell.edu

Debra C Potak, RN

516-838-6434DPotak@northwell.edu

Locations

Cohen Children's Medical Center of New York

Recruiting

New Hyde Park, New York, United States, 11040

Contacts

Debra C Potak, RN

516-838-6436dpotak@northwell.edu

Barry Weinberger, MD

718 470-3440bweinberger@northwell.edu

Principal Investigator:

Barry Weinberger, MD

More Information

Sponsor

Northwell Health

Last update posted

Apr 18, 2023

Last verified

Apr, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2023-04-18.