Application to Predict Neonatal Apnea With Bradycardia

Application to Predict Neonatal Apnea With Bradycardia (APNeA Study)

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.