Clinical trial NCT06637917: Pulse Oximetry Performance Comparison in Newborns
Official title: Pulse Oximetry Performance Comparison in Newborns
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Newborn
Birth, Preterm
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2024-10-15
Enrollment: 120
Sex: ALL
Minimum age (years): 29
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 120 newborns will be selected for this study. A variety of subjects will be targeted for inclusion representing differing stages of development and environments

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


Eligibility criteria: Inclusion Criteria:

* Parent or legal guardian is willing and able to provide informed consent prior to any study procedures being performed.
* 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.
* Subject is ≥ 29 weeks gestational age.
* Subject can accommodate multiple sensors.

Exclusion Criteria:

* 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.
* 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.
* Currently participating in any other study expected to confound study results in the opinion of the investigator.

Primary outcomes:
measure: To compare time to stable signal of heart rate (HR) estimation between two pulse oximeters (PO).
timeFrame: Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours.
measure: To compare overall accuracy of heart rate (HR) estimation between two pulse oximeters (PO) as compared to gold standard electrocardiography (ECG).
timeFrame: Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours.
Secondary outcomes:
measure: To evaluate instances of false bradycardia.
timeFrame: Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours.
measure: To evaluate instances of false bradycardia requiring emergency medical treatment.
timeFrame: Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours.
measure: To evaluate variability in PR between the two PO sensors
timeFrame: Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours.
measure: To compare the number of repositions and replacements required for the two PO sensors during monitoring.
timeFrame: Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai
state: California
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
Study officials:
References: