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NICU Oxygen Control Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04269161
Recruitment Status : Not yet recruiting
First Posted : February 13, 2020
Last Update Posted : March 3, 2020
Sponsor:
Collaborator:
Sacred Heart Health System
Information provided by (Responsible Party):
Roger C Fales, University of Missouri-Columbia

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 48. We will analyze the study as a superiority trial if there is strong evidence of superiority.

Condition or disease Intervention/treatment Phase
Hyperoxia Hypoxia Device: Automatic control of inspired oxygen Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: NICU Oxygen Control Study
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: Automatic Oxygen Control
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.
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.

No Intervention: Manual Oxygen Control
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.



Primary Outcome Measures :
  1. Nurse elapsed time to respond to SpO2 alarm. [ Time Frame: Desaturation events occurring over the 12 6-hour manual study periods. ]
    Mean elapsed time needed for the nurse 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.

  2. Device elapsed time to respond to SpO2 alarm. [ Time Frame: Desaturation events occurring over the 12 6-hour manual study periods. ]
    Mean elapsed time needed for the device 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.


Secondary Outcome Measures :
  1. Time SpO2 is within the prescribed range for manual control by the nurse. [ Time Frame: The 12 6-hour manual study periods. ]
    Proportion of time SpO2 is within the prescribed range computed using an area-under-the-curve approach for data taken during manual control by the nurse.

  2. Time SpO2 is within the prescribed range for automatic control by the device. [ Time Frame: The 12 6-hour manual study periods. ]
    Proportion of time SpO2 is within the prescribed range computed using an area-under-the-curve approach for data taken during automatic control using the device.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Infants admitted to the NICU with congenital heart disease
  • Infants admitted to the NICU whose pulse oximeter range is not set at the 87-95% range by their healthcare team.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04269161


Contacts
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Contact: John A Pardalos, MD (573) 882-2272 Pardalosj@health.missouri.edu

Locations
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United States, Florida
Studer Family Children's Hospital at Sacred Heart
Pensacola, Florida, United States, 32513-2700
Contact: Ramak R Amjad, MD    850-416-7000      
Principal Investigator: Ramak R Amjad, MD         
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65212
Contact: John A Pardalos, MD    573-882-2272    Pardalosj@health.missouri.edu   
Principal Investigator: John A Pardalos, MD         
Sponsors and Collaborators
University of Missouri-Columbia
Sacred Heart Health System
Investigators
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Principal Investigator: John A Pardalos, MD University of Missouri-Columbia

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Responsible Party: Roger C Fales, Associate Professor of Mechanical and Aerospace Engineering, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT04269161    
Other Study ID Numbers: 2003117
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hypoxia
Hyperoxia
Signs and Symptoms, Respiratory
Signs and Symptoms