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Study to Predict Neonatal Apnea with Bradycardia

This study is testing a new approach to help premature babies who experience apnea (when breathing stops) and bradycardia (slow heart rate). It uses a special device called a Closed-loop Vibro-Tactile Stimulator. This device gives gentle vibrations when it predicts or detects that a baby might have a slow heart rate. The study wants to see if this stimulation can stop these episodes before they become serious. You might be able to join if your baby is born between 22 and 32 weeks of pregnancy, has had episodes of apnea with bradycardia in the last 24 hours, and has been off breathing support for more than 48 hours. The main goal is to see if the device can reduce bradycardia episodes where the heart rate drops below 100 beats per minute for 10 seconds or more, during two 4-hour periods.

Study design
This is a randomized cross-over study with 25 participants. It compares a special device that gives gentle vibrations to a sham device (a device that looks real but doesn't do anything).
What's involved
Your baby would have extra ECG leads (stickers to monitor heart activity) connected to a device and laptop for two 4-hour periods. One period involves gentle vibrations, and the other does not.
Compensation
Not stated in the trial record.
Follow-up
The main measurements for this study are taken during two 4-hour periods.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06852053

Application to Predict Neonatal Apnea With Bradycardia

Not Yet Recruiting
NAAges 22–32InterventionalTreatment
University of Alabama at Birmingham
~25 participants
Updated 2026-07-07 on ClinicalTrials.gov
What's tested:Closed-loop Vibro-Tactile StimulatorControl

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Bradycardia <100 beats per minute ≥ 10 seconds
Measured over 4-hours on either intervention.

Conditions

Apnea Neonatal
Bradycardia Neonatal

Explore related trials

ApneaBradycardia

Where it's being run

1 sites across 1 states
Alabama1

Study leadership

  • Colm P. Travers Associate Professor of Pediatrics, M.D. · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham

Who to contact

Rachel L. Benz, Clinical Research Nurse Manager, MSN
[email protected]
205-934-2184
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

a major malformation or a neuromuscular condition that affects respiration or causes apnea, or terminal illness or decision to withhold or limit support.

What this trial measures

  • Bradycardia <100 beats per minute ≥ 10 seconds4-hours on either intervention.

    The frequency of episodes of bradycardia (heart rate less than 100 of ≥ 10 seconds) in either study arm during the study period.