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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 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.

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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.

Conditions Studied

Interventions

  • DEVICE SVS mattress

Study Locations (2)

Alabama

  • University of Alabama - Birmingham

Massachusetts

  • Tufts Medical Center - Boston

Trial Details

FieldValue
Enrollment Target 140 participants
Start Date 2025-02-06
Est. Completion 2026-12-31
Phase NA

Sponsor

Tufts Medical Center

169 total trials

What the Registry Record Tells You About NCT06374147

The ClinicalTrials.gov registry entry for NCT06374147 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 385-participant average among 6 other Apnea of Prematurity trials with a reported enrollment target (64% lower). The listed sponsor is Tufts Medical Center, which has 169 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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