University of Alabama at Birmingham
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.
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.
Vibro-Tactile stimulation when bradycardia is predicted or predicted.
Sham closed-loop vibrotactile stimulator
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