Clinical Evaluation of a Closed Loop Oxygen Controller for Neonatal Respiratory Care

NCT00887731 | Terminated

• 1 other identifier: 30125
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Respiratory Distress Syndrome; Hyperoxia; Prematurity

Keywords

closed loop oxygen controller; premature infants; oxygen exposure

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  12 hours

• Part 3

  12 hrs

Study Arms (3)

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.

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Infant on room air

Sponsors & Collaborators

• University of Utah: lead

Study Sites (2)

Primary Children's Medical Center

Salt Lake City, Utah, 84113, United States

Location

University of Utah Health Sciences Center

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Hyperoxia; Premature Birth

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Donald N-u-l-l, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 22, 2009
• First Posted: April 24, 2009
• Study Start: August 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: September 12, 2013

Record last verified: 2013-09

Locations

US (2)