Continuous Vital Sign Monitoring in Newborns

NCT ID: NCT04154618

Last Updated: 2023-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-18

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Newborn Complication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Continuous wireless vital sign monitoring

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
Minimum Eligible Age

0 Hours

Maximum Eligible Age

12 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

New York State Department of Health

OTHER_GOV

Sponsor Role collaborator

Northwell Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Barry Weinberger

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cohen Children's Medical Center of New York

New Hyde Park, New York, United States

Site Status RECRUITING

Phelps Hospital

Sleepy Hollow, New York, United States

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Barry Weinberger, MD

Role: CONTACT

718-470-3440

Debra C Potak, RN

Role: CONTACT

516-838-6434

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Debra C Potak, RN

Role: primary

516-838-6436

Barry Weinberger, MD

Role: backup

718 470-3440

Mazen T Khalifeh, MD

Role: primary

914-269-1914

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

19-0653

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.