Application to Predict Neonatal Apnea With Bradycardia (APNeA)

The University of Alabama at Birmingham

Status: Begins enrollment in 4 months

Conditions: Bradycardia Neonatal; Apnea Neonatal

Treatments: Device: Control; Device: Closed-loop Vibro-Tactile Stimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT06852053

300008477

UAB (Other Grant/Funding Number)

Details and patient eligibility

About

This purpose of this study is to reduce or stop apneas and bradycardias in pre-term infants, before they occur using gentle stimulation.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 22 to 32 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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25 participants in 2 patient groups

Virbrotactile stimulation

Experimental group

Description:

Four hours of vibrotactile stimulation via a closed loop device if an apnea or bradycardia episode is predicted or detected.

Treatment:

Device: Closed-loop Vibro-Tactile Stimulator

Control

Sham Comparator group

Description:

Four hours of no vibrotactile stimulation via the closed loop device if an apnea or bradycardia episode is predicted or detected.

Treatment:

Device: Control