"Prapela® SVS Incubator Pad for Apnea of Prematurity
ConditionApnea of Prematurity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-3
SponsorTufts Medical Center
About 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
Qualifiers
22 week 0 days-32 weeks 6 days gestational age (preterm)
Either sex
Single birth
At least 4 clinically documented apnea events in the previous 24 hours
Disqualifiers
Intubation and mechanical ventilation, or non-invasive positive pressure ventilation (NIPPV) if not intubated, or pressure support breaths while on CPAP.
Refusal or withdrawal of consent
Major congenital malformations (not including patent ductus arteriosus, small hernia)
Known disorder of breathing other than apnea of prematurity (e.g., congenital central hypoventilation syndrome, laryngotracheomalacia)
Trial design
Treatments tested in this trial
- SVS mattress
Treatment groups
140 Participants
are divided into 2 treatment groupsSponsors and collaborators
Tufts Medical Center
Lead sponsor
University of Alabama at Birmingham
Collaborator
Source ClinicalTrials.gov