Application to Predict Neonatal Apnea With Bradycardia

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06852053
Status
Not Yet Recruiting

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Conditions

  • Apnea Neonatal
  • Bradycardia Neonatal

Eligibility Criteria

Sex
ALL
Age
22 Weeks - 32 Weeks
Healthy Volunteers
Not accepted

Interventions

  • Closed-loop Vibro-Tactile Stimulator — DEVICE
    Vibro-Tactile stimulation when bradycardia is predicted or predicted.
  • Control — DEVICE
    Sham closed-loop vibrotactile stimulator

Study Details

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

Key Dates

Start date
Jul 1, 2026
Status verified
Oct 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Virbrotactile stimulation
    Four hours of vibrotactile stimulation via a closed loop device if an apnea or bradycardia episode is predicted or detected.
  • Sham Comparator: Control
    Four hours of no vibrotactile stimulation via the closed loop device if an apnea or bradycardia episode is predicted or detected.

Primary Outcome Measure

Bradycardia <100 beats per minute ≥ 10 seconds [ Time Frame: 4-hours on either intervention. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35209
Rachel L Benz Clinical Research Nurse Manager, MSN
[email protected]
205-934-2184
Kimberly M. Armstead Clinical Research Coordinator III, B.S.
[email protected]
205-934-0095
Colm P. Travers, M.D. (PRINCIPAL_INVESTIGATOR)

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By research site
University of Alabama at Birmingham· Birmingham, AL

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