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Neonatal Oximeter Bias Study

Study acronym: NOB
StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 25, 2025 (before its estimated August 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Start date: Feb 15, 2025 to Mar 15, 2025v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The study aims to determine if there is a systematic difference (bias) between pulse oximeters used in control systems for automated oxygen delivery (A-FiO2) and those used in monitoring systems. When using A-FiO2 systems there are commonly two oximeter probes on the infant with two difference readouts. Nurses report frustration that the two readings are often markedly different. It is understandable that physiological differences between sensor sites might reflect different regional oxygen saturation levels. It is also possible that there is a relevant systematic bias between difference monitors and sensors. Therefore, a large systematic multicenter study is needed to determine whether these frequent differences should be ignored as physiological noise or considered clinically relevant.
Trial Details
NCT Number NCT06817850
Lead Sponsor Czech Technical University in Prague
Collaborators: University Hospital, Motol
Conditions
(from sponsor)
Neonatal Respiratory Distress, Oxygenation
Related terms Pulmonary Atelectasis
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov