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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
25
Vibro-Tactile stimulation when bradycardia is predicted or predicted.
Sham closed-loop vibrotactile stimulator
University of Alabama at Birmingham
Birmingham, Alabama, United States
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.
Time frame: 4-hours on either intervention.
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.
Time frame: 4 hours in either intervention.
Bradycardia <60 beats per minute ≥ 10 seconds
The frequency of episodes of bradycardia (heart rate \<60 beats per minute ≥ 10 seconds) in either study arm during the study period.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4 hours on either intervention.
Hypoxemia <85% for ≥ 5 seconds
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The frequency of episodes of hypoxemia (oxygen saturations \<85% for ≥ 5 seconds) in either study arm during the study period.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4 hours on either intervention.