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"Prapela® SVS Incubator Pad for Apnea of Prematurity

RecruitingNAAges 0 Days - 3 MonthsAllTufts Medical Center
NCT06374147 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 * 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
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What it tests

  • SVS mattress
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Where

2 sites
University of Alabama
Birmingham, United States
Tufts Medical Center
Boston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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