Application to Predict Neonatal Apnea With Bradycardia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-07-01

Study Completion Date

2027-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Apnea Neonatal Bradycardia Neonatal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Virbrotactile stimulation

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

Group Type EXPERIMENTAL

Closed-loop Vibro-Tactile Stimulator

Intervention Type DEVICE

Vibro-Tactile stimulation when bradycardia is predicted or predicted.

Control

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

Group Type SHAM_COMPARATOR

Control

Intervention Type DEVICE

Sham closed-loop vibrotactile stimulator

Interventions

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Closed-loop Vibro-Tactile Stimulator

Vibro-Tactile stimulation when bradycardia is predicted or predicted.

Intervention Type DEVICE

Control

Sham closed-loop vibrotactile stimulator

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

22 Weeks

Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No