"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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
SVS mattress
DeviceThe intervention group will receive standard therapy plus continuous SVS stimulation using the Prapela SVS incubator pad. The control group will receive only standard therapy, using an inert pad (identical to the SVS pad, its controller, and green light, but without the transducer and therefore incapable of vibration), in order to mask caregivers. Treatment with the pad will continue until an infant is apnea-free for 3 days and \<2 weeks from anticipated discharge or at the clinician's discretion to discontinue treatment. After ending treatment, clinicians will observe patients 24 hours later and if apnea returns, should re-initiate treatment as needed. At 1 and 2 years of age, parents will be contacted for a brief telephone follow up survey to assess neurological development
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: SVS mattress armExperimental treatment 1 intervention
Group B: StandardNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in apnea rate
The primary outcome is a single continuous measure, the change in (AOP), days 0-12 inclusive, from the baseline apneic rate assessed during the 24-hour run-in period, when all infants are treated on standard CC dosing prior to randomization on day 0.
Time frame
7-28 days of interventionSecondary outcomes
1
Secondary Outcome measure
Secondary outcome to be assessed 0 to12 days and 0 to 28 days, inclusive: \- Change in rate of apneic related oxygen desaturation events (SpO2\<80 and \<90%)
Time frame
0 to12 days and 0 to28 days2
Secondary Outcome measure
Secondary outcomes to be assessed 0 to12 days and 0 to 28 days, inclusive: \- Change in rate of apneic associated bradycardia events (HR \< 100beats per/minute)
Time frame
0 to12 days and 0 to28 days3
Secondary Outcome measure
Secondary outcomes to be assessed 0 to12 days and 0 to 28 days, inclusive: \- Cumulative apneic events
Time frame
0 to12 days and 0 to28 days4
Secondary Outcome measures
Secondary outcomes to be assessed 0 to12 days and 0 to 28 days, inclusive: \- Cumulative dosing and length of caffeine citrate treatment
Time frame
0 to12 days and 0 to28 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tufts Medical Center
Lead sponsor
University of Alabama at Birmingham
Collaborator
Source ClinicalTrials.gov