Apnea Neonatal, Bradycardia Neonatal
Conditions
Brief summary
This purpose of this study is to reduce or stop apneas and bradycardias in pre-term infants, before they occur using gentle stimulation.
Detailed description
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.
Interventions
DEVICEClosed-loop Vibro-Tactile Stimulator
Vibro-Tactile stimulation when bradycardia is predicted or predicted.
DEVICEControl
Sham closed-loop vibrotactile stimulator
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Weeks to 32 Weeks
Healthy volunteers
No
Inclusion criteria
* Documented episodes of apnea with bradycardia over the previous 24 hours. * Off ventilatory support/NCPAP for \> 48 hours prior to study entry * Gestational age \< 32 0/7 weeks' gestation at birth * Parents/legal guardians have provided consent for enrollment
Exclusion criteria
* a major malformation or a neuromuscular condition that affects respiration or causes apnea, or terminal illness or decision to withhold or limit support.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bradycardia <100 beats per minute ≥ 10 seconds | 4-hours on either intervention. | The frequency of episodes of bradycardia (heart rate less than 100 of ≥ 10 seconds) in either study arm during the study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bradycardia <60 beats per minute ≥ 5 seconds | 4 hours in either intervention. | The frequency of episodes of bradycardia (heart rate \<60 beats per minute ≥ 5 seconds) in either study arm during the study period. |
| Bradycardia <60 beats per minute ≥ 10 seconds | 4 hours on either intervention. | The frequency of episodes of bradycardia (heart rate \<60 beats per minute ≥ 10 seconds) in either study arm during the study period. |
| Bradycardia <80 beats per minute ≥ 5 seconds | 4 hours on either intervention. | The frequency of episodes of bradycardia (heart rate \<80 beats per minute ≥ 5 seconds) in either study arm during the study period. |
| Bradycardia <80 beats per minute ≥ 10 seconds | 4 hours on either intervention. | The frequency of episodes of bradycardia (heart rate \<80 beats per minute ≥ 10 seconds) in either study arm during the study period. |
| Proportion of time with Bradycardia < 100 beats per minute | 4 hours on either intervention. | The total proportion of time with bradycardia during the study period on either intervention with a heartrate of \<100 beats per minute. |
| Hypoxemia <85% for ≥ 5 seconds | 4 hours on either intervention. | The frequency of episodes of hypoxemia (oxygen saturations \<85% for ≥ 5 seconds) in either study arm during the study period. |
| Hypoxemia <85% for ≥ 10 seconds | 4 hours on either intervention. | The frequency of episodes of hypoxemia (oxygen saturations \<85% for ≥ 10 seconds) in either study arm during the study period. |
| Hypoxemia <90% for ≥ 5 seconds | 4 hours on either intervention. | The frequency of episodes of hypoxemia (oxygen saturations \<90% for ≥ 5 seconds) in either study arm during the study period. |
| Hypoxemia <90% for ≥ 10 seconds | 4 hours on either intervention. | The frequency of episodes of hypoxemia (oxygen saturations \<90% for ≥ 10 seconds) in either study arm during the study period. |
| Hypoxemia <80% for ≥ 5 seconds | 4 hours on either intervention. | The frequency of episodes of hypoxemia (oxygen saturations \<80% for ≥ 5 seconds) in either study arm during the study period. |
| Hypoxemia <80% for ≥ 10 seconds | 4 hours on either intervention. | The frequency of episodes of hypoxemia (oxygen saturations \<80% for ≥ 10 seconds) in either study arm during the study period. |
| Proportion of time with hypoxemia < 90% | 4 hours on either intervention. | The total proportion of time with oxygen saturations \<90% during the study period on either intervention. |
| Bradycardia prediction time | 4 hours on either intervention. | The number of seconds ahead of routine patient monitors at which the device algorithm predicted bradycardia in either group. |
| Bradycardia prediction accuracy | 4 hours on sham control. | The area under the curve for the true prediction rate over the false alarm rate in the control group. |
| Proportion of time with hypoxemia < 85% | 4 hours on either intervention. | The total proportion of time with oxygen saturations \<85% during the study period on either intervention. |
Countries
United States
Contacts
CONTACTRachel L. Benz, Clinical Research Nurse Manager, MSN
CONTACTKimberly M. Armstead Clinical Research Coordinator III, B.S.
PRINCIPAL_INVESTIGATORColm P. Travers Associate Professor of Pediatrics, M.D.
University of Alabama at Birmingham
Outcome results
None listed