NCT04269161

NICU Oxygen Control Study

Completed NA Results posted Last updated 4 July 2025

What this trial tests

NA trial testing Automatic control of inspired oxygen in Hyperoxia in 48 participants. Completed in 6 June 2024.

Timeline

24 May 2022

Primary endpoint
6 June 2024

6 June 2024

Quick facts

Lead sponsor	University of Missouri-Columbia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	48
Start date	24 May 2022
Primary completion	6 June 2024
Estimated completion	6 June 2024
Sites	2 locations across United States

Drugs / interventions tested

• Automatic control of inspired oxygen

Conditions studied

• Hyperoxia — all drugs for Hyperoxia →
• Hypoxia — all drugs for Hypoxia →

Sponsor

University of Missouri-Columbia

Who can join

Eligibility, any sex, with Hyperoxia or Hypoxia. 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.

Elapsed Time to Respond to SpO2 Alarm Primary · Twenty-four study periods consisting of 6-hour manual study periods and 6-hour automatic study periods over six days for each of the subjects in the analysis.

Mean in elapsed time needed to re- establish SpO2 within the desired range after an alarm. The alarms and alarm times are recorded directly from the bedside monitor and the responses are measured directly in terms of the blend valve position and SpO2 response measured by the pulse oximeter.

Group	Value	95% CI
Manual Mode (Nurse)	51.408	± 66.168
Automatic Mode (Device)	41.523	± 30.771

Proportion of Time SpO2 is Within the Prescribed Range in a Six-hour Time Block Secondary · Twelve 6-hour manual study periods and 6-hour automatic study periods over six days for each of the subjects in the analysis.

For each 6-hour time block, we calculate the proportion of time the patient stays within the prescribed SpO2 range. The proportion of time that the SpO2 is within the prescribed range is computed using an area-under-the-curve approach for data taken during automatic control by the experimental device and manual control by the nurse.

Group	Value	95% CI
Manual Mode (Nurse)	0.676	± 0.214
Automatic Mode (Device)	0.695	± 0.224

Sponsor's own description

Prematurely born infants in the hospital neonatal intensive care unit (NICU) will be included in the study. This clinical trial is a randomized crossover study to show that our automated oxygen control device performance is no worse than a NICU nurse in keeping a premature neonate's SPO2 within the prescribed range. Since subjects receive the device (automatic oxygen control) and the standard of care (manual control by a nurse), every subject serves as their own perfectly matched control. Performance measures include the average time it takes for the SpO2 to return to the desired range (primary endpoint) and the total amount of time that the SpO2 is within the desired range (secondary endpoint). The device will be applied to premature infants on respiratory support humidified high flow nasal cannula (HFNC) with oxygen controlled using a blend valve. Two groups include one that begins the study period with the device and one that begins the study period without the device. The two groups are switched between manual and automatic every 6 hours into the trial period and complete a total of 6 days. The target number of subjects is 60. We will analyze the study as a superiority trial if there is strong evidence of superiority.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Automated oxygen delivery for preterm infants with respiratory dysfunction.
   Stafford IG, Lai NM, Tan K. · · 2023 · cited 13× · PMID 38032241 · DOI 10.1002/14651858.cd013294.pub2