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| ID | Type | Description | Link |
|---|---|---|---|
| UAB | Other Identifier | UAB |
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This purpose of this study is to reduce or stop apneas and bradycardias in pre-term infants, before they occur using gentle stimulation.
This will be a randomized cross-over trial that will use additional ECG leads connected to a novel device and laptop to determine the accuracy and efficacy of an algorithm to predict, detect, and interrupt episodes of bradycardia for two 4-hour periods. There will be a 4-hour period without vibro-tactile stimulation and a 4-hour period with vibro-tactile stimulation when episodes are predicted or detected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virbrotactile stimulation | Experimental | Four hours of vibrotactile stimulation via a closed loop device if an apnea or bradycardia episode is predicted or detected. |
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| Control | Sham Comparator | Four hours of no vibrotactile stimulation via the closed loop device if an apnea or bradycardia episode is predicted or detected. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Closed-loop Vibro-Tactile Stimulator | Device | Vibro-Tactile stimulation when bradycardia is predicted or predicted. |
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| Measure | Description | Time Frame |
|---|---|---|
| Bradycardia <100 beats per minute ≥ 10 seconds | The frequency of episodes of bradycardia (heart rate less than 100 of ≥ 10 seconds) in either study arm during the study period. | 4-hours on either intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Bradycardia <60 beats per minute ≥ 5 seconds | The frequency of episodes of bradycardia (heart rate <60 beats per minute ≥ 5 seconds) in either study arm during the study period. | 4 hours in either intervention. |
| Bradycardia <60 beats per minute ≥ 10 seconds |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel L. Benz, Clinical Research Nurse Manager, MSN | Contact | 205-934-2184 | rlbenz@uabmc.edu | |
| Kimberly M. Armstead Clinical Research Coordinator III, B.S. | Contact | 205-934-0095 | karmstead@uabmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Colm P. Travers Associate Professor of Pediatrics, M.D. | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35209 | United States |
Deidentified individual participant data will be made available upon publication through a data use agreement to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be submitted to cptravers@uabmc.edu.
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| Control | Device | Sham closed-loop vibrotactile stimulator |
|
The frequency of episodes of bradycardia (heart rate <60 beats per minute ≥ 10 seconds) in either study arm during the study period. |
| 4 hours on either intervention. |
| Bradycardia <80 beats per minute ≥ 5 seconds | The frequency of episodes of bradycardia (heart rate <80 beats per minute ≥ 5 seconds) in either study arm during the study period. | 4 hours on either intervention. |
| Bradycardia <80 beats per minute ≥ 10 seconds | The frequency of episodes of bradycardia (heart rate <80 beats per minute ≥ 10 seconds) in either study arm during the study period. | 4 hours on either intervention. |
| Proportion of time with Bradycardia < 100 beats per minute | The total proportion of time with bradycardia during the study period on either intervention with a heartrate of <100 beats per minute. | 4 hours on either intervention. |
| Hypoxemia <85% for ≥ 5 seconds | The frequency of episodes of hypoxemia (oxygen saturations <85% for ≥ 5 seconds) in either study arm during the study period. | 4 hours on either intervention. |
| Hypoxemia <85% for ≥ 10 seconds | The frequency of episodes of hypoxemia (oxygen saturations <85% for ≥ 10 seconds) in either study arm during the study period. | 4 hours on either intervention. |
| Hypoxemia <90% for ≥ 5 seconds | The frequency of episodes of hypoxemia (oxygen saturations <90% for ≥ 5 seconds) in either study arm during the study period. | 4 hours on either intervention. |
| Hypoxemia <90% for ≥ 10 seconds | The frequency of episodes of hypoxemia (oxygen saturations <90% for ≥ 10 seconds) in either study arm during the study period. | 4 hours on either intervention. |
| Hypoxemia <80% for ≥ 5 seconds | The frequency of episodes of hypoxemia (oxygen saturations <80% for ≥ 5 seconds) in either study arm during the study period. | 4 hours on either intervention. |
| Hypoxemia <80% for ≥ 10 seconds | The frequency of episodes of hypoxemia (oxygen saturations <80% for ≥ 10 seconds) in either study arm during the study period. | 4 hours on either intervention. |
| Proportion of time with hypoxemia < 90% | The total proportion of time with oxygen saturations <90% during the study period on either intervention. | 4 hours on either intervention. |
| Bradycardia prediction time | The number of seconds ahead of routine patient monitors at which the device algorithm predicted bradycardia in either group. | 4 hours on either intervention. |
| Bradycardia prediction accuracy | The area under the curve for the true prediction rate over the false alarm rate in the control group. | 4 hours on sham control. |
| Proportion of time with hypoxemia < 85% | The total proportion of time with oxygen saturations <85% during the study period on either intervention. | 4 hours on either intervention. |