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Sponsored by: |
University of Utah |
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Information provided by: | University of Utah |
ClinicalTrials.gov Identifier: | NCT00887731 |
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.
Condition |
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Respiratory Distress Syndrome Hyperoxia Prematurity |
Study Type: | Observational |
Study Design: | Case-Crossover, Prospective |
Official Title: | Clinical Evaluation of a Closed Loop Oxygen Controller for Neonatal Respiratory Care |
Estimated Enrollment: | 30 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | April 2011 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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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.
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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.
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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.
Ages Eligible for Study: | up to 3 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Any neonatal intensive care patient who is requiring oxygen therapy as part of their respiratory treatment course will be eligible for this study.
Inclusion Criteria:
Exclusion Criteria:
Contact: Donald N-u-l-l, MD | 801-662-4100 | don.null@hsc.utah.edu |
Contact: Dale Gerstmann, MD | 801-588-3865 |
United States, Utah | |
University of Utah Health Sciences Center | Recruiting |
Salt Lake City, Utah, United States, 84132 | |
Contact: Donald , MD 801-662-4100 don.null@hsc.utah.edu | |
Contact: Dale Gerstmann, MD 801-588-3865 | |
Principal Investigator: Donald N-u-l-l, MD | |
Primary Children's Medical Center | Recruiting |
Salt Lake City, Utah, United States, 84113 | |
Contact: Donald N-u-l-l, MD 801-662-4100 don.null@hsc.utah.edu | |
Principal Investigator: Donald N-u-l-l, MD |
Principal Investigator: | Donald N-u-l-l, MD | University of Utah |
Responsible Party: | University of Utah ( Donald Null ) |
Study ID Numbers: | 30125 |
Study First Received: | April 22, 2009 |
Last Updated: | April 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00887731 History of Changes |
Health Authority: | United States: Institutional Review Board |
closed loop oxygen controller premature infants oxygen exposure |
Hyperoxia Signs and Symptoms Respiratory Tract Diseases Lung Diseases |
Respiration Disorders Respiratory Distress Syndrome, Adult Acute Respiratory Distress Syndrome Signs and Symptoms, Respiratory |
Hyperoxia Signs and Symptoms Pathologic Processes Disease Respiratory Tract Diseases |
Lung Diseases Syndrome Respiration Disorders Respiratory Distress Syndrome, Adult Signs and Symptoms, Respiratory |