NICU Oxygen Control Study

NCT04269161 | Completed Results DMC FDA Device

• 1 other identifier: 2003117
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief 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

Hyperoxia; Hypoxia

Outcome Measures

Primary Outcomes (1)

• Elapsed Time to Respond to SpO2 Alarm

  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.

  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.

Secondary Outcomes (1)

• Proportion of Time SpO2 is Within the Prescribed Range in a Six-hour Time Block

  Twelve 6-hour manual study periods and 6-hour automatic study periods over six days for each of the subjects in the analysis.

Study Arms (2)

Crossover Sequence 1

EXPERIMENTAL

In this arm, an automatic oxygen control device will be used to make adjustments to the blend of oxygen and air supplied to the subject for the first six hours. In this arm, a nurse will manually make adjustments to the blend of oxygen and air supplied to the subject for the second six hours. The study continues in an automatic and manual repeating pattern for six days.

Device: Automatic control of inspired oxygen

Crossover Sequence 2

EXPERIMENTAL

In this arm, a nurse will manually make adjustments to the blend of oxygen and air supplied to the subject as in the standard of care for the first six hours. In this arm, an automatic oxygen control device will be used to make adjustments to the blend of oxygen and air supplied to the subject for the second six hours. The study continues in a manual and automatic repeating pattern for six days.

Device: Automatic control of inspired oxygen

Interventions

Automatic control of inspired oxygen DEVICE

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

Crossover Sequence 1; Crossover Sequence 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Infants admitted to the NICU
• Less than 31 weeks estimated gestational age or less than 1500 grams at birth
• Currently on high flow nasal cannula or bubble CPAP
• Require at least 2 adjustments to the FiO2 per shift and/or have at least 2 desaturation events per shift

You may not qualify if:

• Infants admitted to the NICU with congenital heart disease.
• Infants who are set on a minimum FiO2 set point by their healthcare provider

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• Sacred Heart Health System: collaborator

Study Sites (2)

Studer Family Children's Hospital at Sacred Heart

Pensacola, Florida, 32513-2700, United States

Location

University of Missouri

Columbia, Missouri, 65212, United States

Location

Related Publications (1)

• Hou X, Faqeeh A, Amjad R, Pardalos J, Fales R. Clinical Evaluation of an Automatic Oxygen Control System for Premature Infants Receiving High-Flow Nasal Cannula for Respiratory Support: A Pilot Study. J Med Device. 2022 Sep 1;16(3):031005. doi: 10.1115/1.4054250. Epub 2022 May 10.

  PMID: 35646226 BACKGROUND

MeSH Terms

Conditions

Hyperoxia; Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Roger Fales
• Organization: University of Missouri

falesr@missouri.edu

5738841564

Study Officials

• John A Pardalos, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

• Ramak R Amjad, MD

  Studer Family Children's Hospital at Sacred Heart

  PRINCIPAL INVESTIGATOR

• Roger C Fales, PhD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Mechanical and Aerospace Engineering

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 13, 2020
• Study Start: May 24, 2022
• Primary Completion: June 6, 2024
• Study Completion: June 6, 2024
• Last Updated: July 4, 2025
• Results First Posted: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)