Vibro-Tactile Stimulation for Neonatal Apnea

(APNeA Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Colm P. Travers Associate Professor of Pediatrics, M.D.

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Alabama at Birmingham

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

Research Team

Colm P. Travers Associate Professor of Pediatrics, M.D.

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for pre-term infants born before 32 weeks' gestation, who've had apnea with a slow heart rate in the last day and are off breathing support for over 48 hours. Parents must consent to join. Infants with major malformations, neuromuscular issues affecting breathing, or terminal illness can't participate.

Inclusion Criteria

Parents/legal guardians have provided consent for enrollment

I have not needed a ventilator or CPAP machine for over 48 hours.

My baby was born before 32 weeks of pregnancy.

Exclusion Criteria

Presence of a terminal illness or decision to withhold or limit support.

I have a condition that affects my breathing or causes me to stop breathing.

Treatment Details

Interventions

• Closed-loop Vibro-Tactile Stimulator (Behavioural Intervention)

Trial Overview The study tests if a Closed-loop Vibro-Tactile Stimulator can prevent or reduce episodes of neonatal apnea (pauses in breathing) and bradycardia (slow heart rate). Infants will be randomly assigned to receive this stimulation or placed in a control group without it.

Participant Groups

Group I: Virbrotactile stimulation Experimental Treatment 1 Intervention

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

Group II: Control Placebo Group 1 Intervention

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Alabama at Birmingham Birmingham, AL

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1677

Patients Recruited

2,458,000+

References