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NCT06374147 · ClinicalTrials.gov registry record · NA
"Prapela® SVS Incubator Pad for Apnea of Prematurity
A NA study of Apnea of Prematurity, sponsored by Tufts Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 140
- Enrollment target
- 2
- Study locations
NCT06374147: Recruiting NA study of Apnea of Prematurity, sponsored by Tufts Medical Center.
NCT06374147 is a NA study of Apnea of Prematurity that is actively recruiting participants, run by Tufts Medical Center. The registered enrollment target is 140 participants, below the 385-participant average among 6 other Apnea of Prematurity trials with a reported enrollment target (64% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06374147, a NA study of Apnea of Prematurity, is actively recruiting participants, sponsored by Tufts Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 140 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
The primary outcome is a single continuous measure, the change in (AOP), days 0-12 inclusive, from the baseline apneic rate assessed during the 24-hour run-in period, when all infants are treated on standard CC dosing prior to randomization on day 0.
Conditions Studied
Interventions
- DEVICE SVS mattress
Study Locations (2)
Alabama
- University of Alabama - Birmingham
Massachusetts
- Tufts Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2025-02-06 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
What NCT06374147 shows while recruiting
NCT06374147 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 385-participant average among 6 other Apnea of Prematurity trials with a reported enrollment target (64% lower).
The record links to 1 condition, with Apnea of Prematurity appearing as the primary indexed condition, and to 1 intervention - of which SVS mattress is the first listed.
NCT06374147 reports a single indexed study location in Alabama, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06374147 about?
NCT06374147 is a clinical study titled ""Prapela® SVS Incubator Pad for Apnea of Prematurity". 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 ap...
What is the current status of trial NCT06374147?
This trial is currently recruiting. It is a NA study. The enrollment target is 140 participants. The study started on 2025-02-06. Estimated completion is 2026-12-31.
What conditions does trial NCT06374147 study?
This clinical trial studies the following conditions: Apnea of Prematurity.
What interventions are being tested in trial NCT06374147?
The interventions under investigation include: SVS mattress (DEVICE).
Who is sponsoring clinical trial NCT06374147?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06374147 being conducted?
This trial has 2 study locations across Alabama, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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