Clinical Trial

"Prapela® SVS Incubator Pad for Apnea of Prematurity

Study acronym: Prapela AOP
Recruiting
View on ClinicalTrials.gov →
Summary
The study proposes to complete the development of and then establish the safety, efficacy, and clinical risk/benefit of a novel hospital incubator pad with stochastic vibrotactile stimulation (SVS) that will provide a complementary treatment and the first improvement in the clinical management of apnea of prematurity (AOP) in over 20 years. Currently, the only approved therapy for AOP is Caffeine Citrate. The SVS mattress pad can prove to be an effective, non-invasive adjunct to Caffeine Citrate for preterm infants with potential to shorten the need for respiratory support as well as overall shortened length of stay.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-04-16; most recent amendment 2025-03-04.
Status change: Not Yet Recruiting → Recruiting 2025-03-04
Trial Details
NCT Number NCT06374147
Lead Sponsor Tufts Medical Center
Collaborators: University of Alabama at Birmingham
Conditions Apnea of Prematurity
Enrollment 140 participants
Start Date 2025-02-06
Primary Completion 2026-10-01 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-03-07