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NCT05250102

Neonatal Pulse Oximetry Sensor Study

Completed NA Results posted Last updated 30 October 2024
What this trial tests

NA trial testing Pulse oximeter sensors in Premature Birth in 23 participants. Completed in 10 October 2023.

Timeline
13 June 2022
Primary endpoint
10 October 2023
10 October 2023

Quick facts

Lead sponsorMedline Industries
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment23
Start date13 June 2022
Primary completion10 October 2023
Estimated completion10 October 2023
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Medline Industries — full company profile →

Who can join

Adults 1 Day to 28 Days, any sex, with Premature Birth. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Bland-Altman Analysis for Nellcor Pulse Oximeter Primary · 15 episodic minutes

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.

Bias Massimo
GroupValue95% CI
Sensor Massimo or Nellcor.151-.361 – .662
Bias Nellcor
GroupValue95% CI
Sensor Massimo or Nellcor.434-.149 – 1.017

Sponsor's own description

To validate the SpO2 accuracy, bias, and precision of Medline's reprocessed pulse oximetry sensors as compared to SaO2 in arterial blood samples as assessed by CO-oximetry in neonates.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Premature Birth

Currently open trials in the same condition.

Other Medline Industries trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05250102.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing