Trial Outcomes & Findings for Neonatal Pulse Oximetry Sensor Study (NCT NCT05250102)

Last Updated: 2024-10-30

Results Overview

BIAS Measurement and 95% confidence interval calculated using a Bland-Altman plot (mean vs. difference of SaO2 and SpO2) and an error plot (SaO2 vs. difference of SaO2 and SpO2) were generated. The B\&A plot analysis is a simple way to evaluate a bias between the mean differences, and to estimate an agreement interval, within which 95% of the differences of the second method, compared to the first one, fall. Data can be analyzed both as unit differences plot and as percentage differences plot. We ran a percentage mean difference plot.

Recruitment status

COMPLETED

Study phase

Target enrollment

23 participants

Primary outcome timeframe

15 episodic minutes

Results posted on

2024-10-30

Participant Flow

a total of 23 neonates were recruited for the study, with 1-3 measurement pairs taken for each subject and each pulse oximetry sensor, for a total of 2, 4, or 6 measurement pairs per subject.

Participant milestones

Participant milestones
Measure	Pulse Oximeter Sensor Readings Subjects who satisfy all of the inclusion criteria will be eligible to participate in the study, will receive intervention (the Masimo and Nellcor sensors, and their arterial blood sample will be taken in the normal course of care). This is a single arm study. Those who don't meet the inclusion/ exclusion criteria won't be eligible to participate. Pulse oximeter sensors: Pulse oximeter reading will be compared to CO-oximeter reading.
Overall Study STARTED	23
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neonatal Pulse Oximetry Sensor Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pulse Oximeter Sensor Readings n=23 Participants Subjects who satisfy all of the inclusion criteria will be eligible to participate in the study, will receive intervention (the Masimo and Nellcor sensors, and their arterial blood sample will be taken in the normal course of care). This is a single arm study. Those who don't meet the inclusion/ exclusion criteria won't be eligible to participate. Pulse oximeter sensors: Pulse oximeter reading will be compared to CO-oximeter reading.
Age, Categorical <=18 years	23 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	23.6 Weeks STANDARD_DEVIATION 1.6 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	14 Participants n=5 Participants
Race/Ethnicity, Customized White - Non Hispanic or Latino	8 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 15 episodic minutes

Population: all neonates participating in the study

Outcome measures

Outcome measures
Measure	Sensor Massimo or Nellcor n=23 Participants Each participant wore massimo and nellcor sensors at the same time. Readings were taken from each sensor.
Bland-Altman Analysis for Nellcor Pulse Oximeter Bias Massimo	.151 percentage of difference in mean Interval -0.361 to 0.662
Bland-Altman Analysis for Nellcor Pulse Oximeter Bias Nellcor	.434 percentage of difference in mean Interval -0.149 to 1.017

Adverse Events

Pulse Oximeter Sensor Readings

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Julie J. Finley

Medline Industries, LP

Phone: (800) 633-5463

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60