NCT06374147 · Tufts Medical Center
"Prapela® SVS Incubator Pad for Apnea of Prematurity
(Prapela AOP)
What this study is about
The study proposes to complete the development of and then establish the safety, effectiveness, 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.
View original scientific description
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.
Interventions
DEVICE
SVS mattress
The 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
Primary outcome measures
Change in apnea rate
Time frame: 7-28 days of intervention
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 22 week 0 days-32 weeks 6 days gestational age (preterm)
- Single birth
- At least 4 clinically documented apnea events in the previous 24 hours
- Caffeine citrate at least 5 mg/kg/day dosing, with or without respiratory support oxygen, nasal cannula, or CPAP without and added rate or pressure support, if considered necessary by the clinical team)
Exclusion criteria
- 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)
- Caffeine citrate dosing exceeding FDA recommended dosing in the first 24 hours, if deemed necessary by the clinical team
Where
- Birmingham, Alabama
- Boston, Massachusetts
Collaborators
University of Alabama at Birmingham
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 7, 2025 · Source of record for eligibility and locations