Actively Recruiting
Prapela4 SVS Incubator Pad: a Cost-effective Stochastic Vibrotactile Device to Improve the Clinical Course of Infants with Apnea of Prematurity
Led by Tufts Medical Center · Updated on 2025-03-07
140
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
Sponsors
T
Tufts Medical Center
Lead Sponsor
U
University of Alabama at Birmingham
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new hospital incubator pad that provides stochastic vibrotactile stimulation (SVS) as a complementary treatment for apnea of prematurity (AOP), a common condition in preterm infants where breathing stops for 20 seconds or more. This study aims to establish the safety, effectiveness, and clinical risks and benefits of this device, which could improve management of AOP beyond the current standard therapy of caffeine citrate. The study focuses on newborns born before 33 weeks gestational age and younger than 38 weeks postmenstrual age at enrollment. The study compares two groups: one receiving standard therapy with caffeine citrate plus continuous SVS stimulation via the Prapela SVS incubator pad, and a control group receiving standard therapy with an inert pad that looks identical but does not vibrate. Treatment with the SVS pad continues until the infant is apnea-free for three days and less than two weeks from anticipated discharge, or until the clinician decides to stop. If apnea returns after stopping, treatment may be restarted. Follow-up surveys will be conducted by telephone at 1 and 2 years of age to assess neurological development. Participants will be monitored closely with clinical evaluations and questionnaires completed by clinicians to assess risks and benefits. The primary outcome is the change in apnea rate during 7 to 28 days of intervention, with secondary outcomes assessed at earlier time points. The study is randomized and single-masked, with safety and efficacy data gathered to support possible FDA clearance and future use of the SVS incubator pad as an adjunctive therapy to improve outcomes in preterm infants with AOP.
CONDITIONS
Brief Title
"Prapela® SVS Incubator Pad for Apnea of Prematurity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Gestational age between 22 weeks 0 days and 32 weeks 6 days
- Infant of either sex
- Single birth
- At least 4 clinically documented apnea events in the previous 24 hours
- Receiving caffeine citrate at a dose of at least 5 mg/kg/day, with or without respiratory support such as oxygen, nasal cannula, or CPAP without added rate or pressure support
You will not qualify if you...
- Use of intubation and mechanical ventilation, or non-invasive positive pressure ventilation if not intubated, or pressure support breaths while on CPAP
- Refusal or withdrawal of consent
- Major congenital malformations excluding patent ductus arteriosus or small hernia
- Known breathing disorders other than apnea of prematurity, such as congenital central hypoventilation syndrome or laryngotracheomalacia
- Caffeine citrate dosing exceeding FDA recommended levels in the first 24 hours if deemed necessary by the clinical team
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 7 to 28 days
Participants receive standard therapy with caffeine citrate and respiratory support. The intervention group will also receive continuous stimulation using the Prapela SVS incubator pad, while the control group will use an inert pad. Treatment continues until the infant is apnea-free for 3 days and less than 2 weeks from anticipated discharge, or as determined by clinicians. After treatment ends, patients are observed for 24 hours to monitor apnea recurrence.
Continuous monitoring during treatment period with clinical assessments as part of routine care
Duration - Up to 2 years post-treatment
Parents are contacted by telephone at 1 and 2 years of age for brief surveys to assess neurological development of the infants.
2 telephone follow-up contacts
Trial Site Locations
Total: 2 locations
1
University of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
Research Team
R
Rachana Singh, MD, MS
J
John Konsin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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