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Device
Automated Oxygen Control for Premature Infants' Oxygen Levels
N/A
Recruiting
Led By John A Pardalos, MD
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Currently on high flow nasal cannula or bubble CPAP
Infants admitted to the NICU
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the 12 6-hour manual study periods.
Awards & highlights
Study Summary
This trial is testing whether an automated oxygen control device is better than manual control by a NICU nurse in keeping a premature neonate's SPO2 within the prescribed range.
Who is the study for?
This trial is for premature infants in the NICU who are on high flow nasal cannula or bubble CPAP, need oxygen adjustments frequently, and are less than 31 weeks gestational age or under 1500 grams at birth. Infants with congenital heart disease or a set minimum FiO2 by their provider cannot join.Check my eligibility
What is being tested?
The study tests an automated oxygen control device against manual control by nurses to keep a preemie's SpO2 within target range. It's a crossover study where each baby experiences both methods, switching every 6 hours over six days to compare effectiveness.See study design
What are the potential side effects?
Since the intervention involves standard care procedures (oxygen delivery), side effects may not be directly from the device but can include potential risks associated with improper oxygen levels such as hypoxia or hyperoxia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently using a high flow nasal cannula or bubble CPAP.
Select...
My infant is currently in the NICU.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the 12 6-hour manual study periods.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the 12 6-hour manual study periods.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Device elapsed time to respond to SpO2 alarm.
Nurse elapsed time to respond to SpO2 alarm.
Secondary outcome measures
Time SpO2 is within the prescribed range for automatic control by the device.
Time SpO2 is within the prescribed range for manual control by the nurse.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Automatic Oxygen ControlExperimental Treatment1 Intervention
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.
Group II: Manual Oxygen ControlActive Control1 Intervention
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.
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Who is running the clinical trial?
University of Missouri-ColumbiaLead Sponsor
362 Previous Clinical Trials
628,054 Total Patients Enrolled
3 Trials studying Hypoxia
129 Patients Enrolled for Hypoxia
Sacred Heart Health SystemOTHER
1 Previous Clinical Trials
438 Total Patients Enrolled
John A Pardalos, MDPrincipal InvestigatorUniversity of Missouri-Columbia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently using a high flow nasal cannula or bubble CPAP.My oxygen levels need frequent adjustments or drop often.My infant has a specific oxygen level set by their doctor.My baby has heart disease and is in the NICU.My infant is currently in the NICU.You were born less than 31 weeks early or weighed less than 1500 grams at birth.
Research Study Groups:
This trial has the following groups:- Group 1: Automatic Oxygen Control
- Group 2: Manual Oxygen Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aggregate of participants in this clinical exploration?
"Affirmative. According to the records on clinicaltrials.gov, this scientific investigation is still in its recruitment phase since it was first posted on May 24th 2022 and last revised on May 23rd 2022. The study has a target of 60 participants from 2 separate sites."
Answered by AI
Is enrollment for this study still open to participants?
"Affirmative, according to records on clinicaltrials.gov the current recruitment status of this medical trial is active. The first posting for the study was made on May 24th 2022 and it has since been updated with new information on June 23rd 2022. This research aims to admit 60 participants from two different medical facilities."
Answered by AI
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