ACTIVE_NOT_RECRUITING

Pulse Oximetry Performance Comparison in Newborns

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Conditions

NewbornBirth, Preterm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The overall purpose is to directly compare pulse rate (PR) acquisition and oxygen saturation performance between two pulse oximeters (PO) in newborns.

Official Title

Pulse Oximetry Performance Comparison in Newborns

Quick Facts

Study Start:2024-09-10
Study Completion:2025-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06637917

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:29 Weeks
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Parent or legal guardian is willing and able to provide informed consent prior to any study procedures being performed.
  2. * Subject is expected to be able to participate for the duration of the evaluation in the delivery room. In most instances, the length of the study will not exceed the anticipated duration of ECG monitoring.
  3. * Subject is ≥ 29 weeks gestational age.
  4. * Subject can accommodate multiple sensors.
  1. * Subjects that have an existing health condition, in which the investigator determines that safe or accurate oximetry measures may not be obtained at the areas where the PO sensor could be placed. For example, major congenital anomalies, limb anomalies or anyone with abrasions or surface lesions on the contact areas would be excluded.
  2. * Any subject whose treatment or condition would be compromised if they were to participate in this study and any patient whose use of a pulse oximeter and sensor would present a potential for serious risk to health, safety, or welfare.
  3. * Currently participating in any other study expected to confound study results in the opinion of the investigator.

Contacts and Locations

Study Locations (Sites)

Cedars-Sinai
Los Angeles, California, 90048
United States
Washington University in St. Louis
St Louis, Missouri, 63130
United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
United States

Collaborators and Investigators

Sponsor: Medtronic - MITG

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-10
Study Completion Date2025-11

Study Record Updates

Study Start Date2024-09-10
Study Completion Date2025-11

Terms related to this study

Additional Relevant MeSH Terms

  • Newborn
  • Birth, Preterm