Actively Recruiting
"Prapela® SVS Incubator Pad for Apnea of Prematurity
Led by Tufts Medical Center · Updated on 2025-03-07
140
Participants Needed
2
Research Sites
99 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
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
Official 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
- 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 (oxygen, nasal cannula, or CPAP without added rate or pressure support) as needed by clinical team
You will not qualify if you...
- Intubation and mechanical ventilation
- Use of non-invasive positive pressure ventilation (NIPPV) if not intubated
- Use of pressure support breaths while on CPAP
- Refusal or withdrawal of consent
- Major congenital malformations (except patent ductus arteriosus or small hernia)
- Known breathing disorders other than apnea of prematurity (e.g., congenital central hypoventilation syndrome, laryngotracheomalacia)
- Caffeine citrate dosing exceeding FDA recommended dose in the first 24 hours if deemed necessary by clinical team
AI-Screening
AI-Powered Screening
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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
CONTACT
J
John Konsin
CONTACT
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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