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NICU Oxygen Control Study

NCT04269161 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-07-04

Study results available
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Summary

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.

Conditions

Interventions

DEVICE

Automatic control of inspired oxygen

A device will be used to automatically adjust the blend of oxygen and air with the ability to return to manual control as needed.

Sponsors & Collaborators

  • Sacred Heart Health System

    collaborator OTHER

  • University of Missouri-Columbia

    lead OTHER

Principal Investigators

  • John A Pardalos, MD · University of Missouri-Columbia

  • Ramak R Amjad, MD · Studer Family Children's Hospital at Sacred Heart

  • Roger C Fales, PhD · University of Missouri-Columbia

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-24
Primary Completion
2024-06-06
Completion
2024-06-06
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04269161 on ClinicalTrials.gov