SVS Incubator Pad for Apnea of Prematurity
(Prapela AOP Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if participants must stop taking their current medications. However, it mentions that participants should be on a certain dose of Caffeine Citrate, which suggests that continuing this medication is required.
What data supports the effectiveness of the SVS Incubator Pad treatment for apnea of prematurity?
How does the SVS Incubator Pad treatment for apnea of prematurity differ from other treatments?
The SVS Incubator Pad is unique because it likely uses a noninvasive method similar to vertical pulsating stimulation (VPS), which helps reduce central and mixed apnea episodes in preterm infants. This approach is different from standard treatments like cutaneous stimulation or continuous positive airway pressure, as it is easy to implement and non-toxic.12367
What is the purpose of this trial?
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.
Eligibility Criteria
This trial is for preterm infants born between 22 and nearly 33 weeks, experiencing at least four apnea events in the last day. They must be on a stable dose of Caffeine Citrate and may use certain respiratory supports. Infants with major birth defects (except small hernia or patent ductus arteriosus) or other breathing disorders, or those needing more intensive respiratory support are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive standard therapy with caffeine citrate and either an inert or active SVS incubator pad
Follow-up
Participants are monitored for safety and effectiveness after treatment
Observation
Clinicians observe patients for 24 hours after treatment ends to monitor for return of apnea
Treatment Details
Interventions
- SVS Incubator Pad
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tufts Medical Center
Lead Sponsor
University of Alabama at Birmingham
Collaborator