NCT06374147 "Prapela® SVS Incubator Pad for Apnea of Prematurity
| NCT ID | NCT06374147 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tufts Medical Center |
| Condition | Apnea of Prematurity |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-02-06 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2025-02-06 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06374147 clinical trial?
This trial is open to participants of all sexes, aged 0 Days or older, up to 3 Months, studying Apnea of Prematurity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06374147 currently recruiting?
Yes, NCT06374147 is actively recruiting participants. Contact the research team at rachana.singh1@tuftsmedicine.org for enrollment information.
Where is the NCT06374147 trial being conducted?
This trial is being conducted at Birmingham, United States, Boston, United States.
Who is sponsoring the NCT06374147 clinical trial?
NCT06374147 is sponsored by Tufts Medical Center. The trial plans to enroll 140 participants.