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Application to Predict Neonatal Apnea With Bradycardia

NCT06852053 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-01-23

No results posted yet for this study

Summary

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

Conditions

  • Apnea Neonatal
  • Bradycardia Neonatal

Interventions

DEVICE

Closed-loop Vibro-Tactile Stimulator

Vibro-Tactile stimulation when bradycardia is predicted or predicted.

DEVICE

Control

Sham closed-loop vibrotactile stimulator

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
22 Weeks
Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06852053 on ClinicalTrials.gov