Application to Predict Neonatal Apnea With Bradycardia (APNeA Study)
University of Alabama at Birmingham
Summary
This purpose of this study is to reduce or stop apneas and bradycardias in pre-term infants, before they occur using gentle stimulation.
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.
Eligibility
- Age range
- 0–0 years
- Sex
- All
- 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.
Interventions
- DeviceClosed-loop Vibro-Tactile Stimulator
Vibro-Tactile stimulation when bradycardia is predicted or predicted.
- DeviceControl
Sham closed-loop vibrotactile stimulator
Location
- University of Alabama at BirminghamBirmingham, Alabama