NCT06852053NARecruiting
Application to Predict Neonatal Apnea With Bradycardia
University of Alabama at Birmingham
Start Date
9/29/2026
Completion Date
12/31/2028
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.
Eligibility Criteria
Age Range: No minimum to No maximum
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
DEVICE
Closed-loop Vibro-Tactile Stimulator
DEVICE
Control
Conditions
Apnea NeonatalBradycardia Neonatal
Locations
University of Alabama at Birmingham
Birmingham, Alabama 35209
United States