Respiratory Distress SyndromeNCT00887731
Clinical Evaluation of a Closed Loop Oxygen Controller for Neonatal Respiratory Care
An observational study of Respiratory Distress Syndrome and Hyperoxia, run by University of Utah at 2 sites in United States.
Trial summary
Nearly forty years ago Berran and coworkers tested an analog oxygen controller to maintain incubator oxygen levels for infants suffering neonatal respiratory disease in order to prevent hyperoxia. Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Respiratory Distress Syndrome, Hyperoxia, Prematurity
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2009to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 months
- All sexes
- No healthy volunteers
- Child
Study population: Any neonatal intensive care patient who is requiring oxygen therapy as part of their respiratory treatment course will be eligible for this study.
Who may be able to join
- Any neonatal intensive care patient who is requiring oxygen therapy as part of their respiratory treatment course will be eligible for this study.
- Parental consent
Who cannot join
- Infant on room air
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Primary Children's Medical Center
Salt Lake City, Utah, 84113
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
About this study
Nearly forty years ago Berran and coworkers tested an analog oxygen controller to maintain incubator oxygen levels for infants suffering neonatal respiratory disease in order to prevent hyperoxia.
There are at least three clinical issues that this technology addresses: the first is avoidance of episodic hyperoxia; the second is decreasing episodic hypoxia; and the third is lowering cumulative oxygen exposure.
Read more
Clinical trials which have used target SpO2 ranging probably help improve all of these problems, but so far there have been no direct measurements of continuous arterial oxygen levels, nor clinical studies which establish the degree to which improving control over blood oxygen saturation decreases the cumulative amount of oxygen exposure. This study will address the later and is an important step in the process of incorporating closed-loop oxygen control technology as a routine standard of neonatal respiratory care.
OBJECTIVES:
PART 1: Test and modify the instruction set for the computerized oxygen controller to achieve a goal of less than six (6) operator required interruptions per hour for oxygen saturation deviations outside of study guidelines.
PART 2: Perform a within patient cross-over trial of the computerized oxygen controller versus standard of care (the patient's care team adjusts the patient's oxygen level) and evaluate the area under the time curve for oxygen exposure between the two control methods.
PART 3:(After successful completion of PART 2) Continuation of the within patient cross-over study with a randomized cross-over sequence. Studies will last 4 to 12 hours divided in two (2) equal time blocks with one cross-over to either automatic or manual control modes. Provision for up to an additional twenty (20) patients to be studied.
Read the detailed description
Nearly forty years ago Berran and coworkers tested an analog oxygen controller to maintain incubator oxygen levels for infants suffering neonatal respiratory disease in order to prevent hyperoxia.
- The system was able to regulate to within 1% of the set inspired oxygen level and resulted in stable infant arterial oxygen levels measured transcutaneously. Twenty years later, with the advent of pulse oximetry and computer technology, open loop control of infant oxygen saturation was studied in newborns using computer programs incorporating fuzzy logic and clinical algorithms.
- During computer-assisted inspired oxygen adjustment there was less variability in pulse oximeter oxygen saturation levels (SpO2) and patients spent more time within the target oxygen saturation range. The next technology step was to move from open to closed loop control, as was done by Claure et al in 2001.
- These investigators found that closed loop control of inspired oxygen was at least as effective as a fully dedicated nurse in maintaining SpO2 within the target range, and that it may be more effective than a nurse working under routine conditions. Percent of recording time spent at normoxia increased from 66% to 75%. Other bench research suggests that closed loop oxygen controllers based on SpO2 monitoring can have response times within 20 seconds and be able to maintain SpO2 within three percent saturation.
- In a clinical crossover trial it was shown that compared to routine inspired oxygen control management by bedside personnel, closed loop control of inspired oxygen concentration significantly increased time within target saturation range from 82% to 91%.
- The importance of controlling oxygen exposure in neonates has been long standing, especially as it relates to retinopathy of prematurity and bronchopulmonary dysplasia. The prospect for decreasing oxygen related morbidities is still a real and an ongoing topic for process change directed to overcoming treatment barriers.
- Maintaining oxygen saturation tightly within appropriate treatment ranges appears to improve both short and long term outcomes, including developmental indices.
- Given the improvement in oxygen exposure that can be realized by closed-loop control of inspired oxygen concentration as demonstrated above, the development of commercial devices that incorporate this technology is highly desirable and a positive move toward uniform control of oxygen exposure for neonates. There are at least three clinical issues that this technology addresses: the first is avoidance of episodic hyperoxia; the second is decreasing episodic hypoxia; and the third is lowering cumulative oxygen exposure.
- Conditions
- Respiratory Distress Syndrome, Hyperoxia, Prematurity
- Keywords
- closed loop oxygen controller, premature infants, oxygen exposure
- Medical subject headings
- Respiratory Distress Syndrome, Hyperoxia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 group | Observational study with a convenience sample of ten (10) patients. PART 1 will end when at least 3 of 4 consecutive patients achieve the goal of less than six (6) operator required interruptions per hour for oxygen saturation deviations from study guidelines, or at ten (10) patients. | |
| Part 2 group | (After successful completion of PART 1) Within patient cross-over study with a randomized cross-over sequence. Sequential data analysis methods will be used to help minimize the patient sample size which will be no more than twenty (20) patients plus up to a maximum of seven (7) who might be eligible from PART 1. | |
| Part 3 Group | (After successful completion of PART 2) Within patient cross-over study with a randomized cross-over sequence. Studies will last 4 to 12 hours divided in two (2) equal time blocks with one cross-over to either automatic or manual control modes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PART 1: Test and modify the instruction set for the computerized oxygen controller to achieve a goal of less than six (6) operator required interruptions per hour for oxygen saturation deviations outside of study guidelines.
Measured: 2-4 hours
Secondary outcomes (2)
PART 2: Perform a within patient cross-over trial of the computerized oxygen controller versus standard of care and evaluate the area under the time curve for oxygen exposure between the two control methods.
Measured: 12 hours
Part 3
Perform a within patient cross-over trial of the computerized oxygen controller versus standard of care and evaluate the area under the time curve for oxygen exposure between the two control methods. Studies will last 4 to 12 hours divided in two (2) equal time blocks with one cross-over to either automatic or manual control modes.
Measured: 12 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2009 (estimated)
- Study startAug 2009
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Investigators
- Donald N-u-l-l, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00887731
- Sponsor's protocol ID
- 30125
- Status last verified
- Sep 2013
- First submitted
- 22 Apr 2009
- Last updated
- 12 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Closed Loop Oxygen Controller for Neonatal Respiratory Care
- ClinicalTrials.gov ID
- NCT00887731
- Acronym / sponsor ID
- 30125
- Conditions
- Respiratory Distress Syndrome, Hyperoxia, Prematurity
- Keywords
- closed loop oxygen controller, premature infants, oxygen exposure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: slow enrollment
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 24 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nearly forty years ago Berran and coworkers tested an analog oxygen controller to maintain incubator oxygen levels for infants suffering neonatal respiratory disease in order to prevent hyperoxia.
There are at least three clinical issues that this technology addresses: the first is avoidance of episodic hyperoxia; the second is decreasing episodic hypoxia; and the third is lowering cumulative oxygen exposure.
Clinical trials which have used target SpO2 ranging probably help improve all of these problems, but so far there have been no direct measurements of continuous arterial oxygen levels, nor clinical studies which establish the degree to which improving control over blood oxygen saturation decreases the cumulative amount of oxygen exposure. This study will address the later and is an important step in the process of incorporating closed-loop oxygen control technology as a routine standard of neonatal respiratory care.
OBJECTIVES:
PART 1: Test and modify the instruction set for the computerized oxygen controller to achieve a goal of less than six (6) operator required interruptions per hour for oxygen saturation deviations outside of study guidelines.
PART 2: Perform a within patient cross-over trial of the computerized oxygen controller versus standard of care (the patient's care team adjusts the patient's oxygen level) and evaluate the area under the time curve for oxygen exposure between the two control methods.
PART 3:(After successful completion of PART 2) Continuation of the within patient cross-over study with a randomized cross-over sequence. Studies will last 4 to 12 hours divided in two (2) equal time blocks with one cross-over to either automatic or manual control modes. Provision for up to an additional twenty (20) patients to be studied.
Detailed description
Nearly forty years ago Berran and coworkers tested an analog oxygen controller to maintain incubator oxygen levels for infants suffering neonatal respiratory disease in order to prevent hyperoxia.
- The system was able to regulate to within 1% of the set inspired oxygen level and resulted in stable infant arterial oxygen levels measured transcutaneously. Twenty years later, with the advent of pulse oximetry and computer technology, open loop control of infant oxygen saturation was studied in newborns using computer programs incorporating fuzzy logic and clinical algorithms.
- During computer-assisted inspired oxygen adjustment there was less variability in pulse oximeter oxygen saturation levels (SpO2) and patients spent more time within the target oxygen saturation range. The next technology step was to move from open to closed loop control, as was done by Claure et al in 2001.
- These investigators found that closed loop control of inspired oxygen was at least as effective as a fully dedicated nurse in maintaining SpO2 within the target range, and that it may be more effective than a nurse working under routine conditions. Percent of recording time spent at normoxia increased from 66% to 75%. Other bench research suggests that closed loop oxygen controllers based on SpO2 monitoring can have response times within 20 seconds and be able to maintain SpO2 within three percent saturation.
- In a clinical crossover trial it was shown that compared to routine inspired oxygen control management by bedside personnel, closed loop control of inspired oxygen concentration significantly increased time within target saturation range from 82% to 91%.
- The importance of controlling oxygen exposure in neonates has been long standing, especially as it relates to retinopathy of prematurity and bronchopulmonary dysplasia. The prospect for decreasing oxygen related morbidities is still a real and an ongoing topic for process change directed to overcoming treatment barriers.
- Maintaining oxygen saturation tightly within appropriate treatment ranges appears to improve both short and long term outcomes, including developmental indices.
- Given the improvement in oxygen exposure that can be realized by closed-loop control of inspired oxygen concentration as demonstrated above, the development of commercial devices that incorporate this technology is highly desirable and a positive move toward uniform control of oxygen exposure for neonates. There are at least three clinical issues that this technology addresses: the first is avoidance of episodic hyperoxia; the second is decreasing episodic hypoxia; and the third is lowering cumulative oxygen exposure.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 group | – | –Observational study with a convenience sample of ten (10) patients. PART 1 will end when at least 3 of 4 consecutive patients achieve the goal of less than six (6) operator required interruptions per hour for oxygen saturation deviations from study guidelines, or at ten (10) patients. |
| Part 2 group | – | –(After successful completion of PART 1) Within patient cross-over study with a randomized cross-over sequence. Sequential data analysis methods will be used to help minimize the patient sample size which will be no more than twenty (20) patients plus up to a maximum of seven (7) who might be eligible from PART 1. |
| Part 3 Group | – | –(After successful completion of PART 2) Within patient cross-over study with a randomized cross-over sequence. Studies will last 4 to 12 hours divided in two (2) equal time blocks with one cross-over to either automatic or manual control modes. |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Any neonatal intensive care patient who is requiring oxygen therapy as part of their respiratory treatment course will be eligible for this study.
Key inclusion criteria (2 listed)
- Any neonatal intensive care patient who is requiring oxygen therapy as part of their respiratory treatment course will be eligible for this study.
- Parental consent
Key exclusion criteria (1 listed)
- Infant on room air
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PART 1: Test and modify the instruction set for the computerized oxygen controller to achieve a goal of less than six (6) operator required interruptions per hour for oxygen saturation deviations outside of study guidelines.
Time frame: 2-4 hours
2 secondary outcomes
PART 2: Perform a within patient cross-over trial of the computerized oxygen controller versus standard of care and evaluate the area under the time curve for oxygen exposure between the two control methods.
Time frame: 12 hours
Part 3
Time frame: 12 hrs
Results and safety
The study was stopped early (reason given: slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald N-u-l-l, MD principal investigator
University of Utah
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome and Hyperoxia, run by University of Utah at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PART 1: Test and modify the instruction set for the computerized oxygen controller to achieve a goal of less than six (6) operator required interruptions per hour for oxygen saturation deviations outside of study guidelines. (time frame: 2-4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2013.