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NCT06374147: Prapela AOP
"Prapela® SVS Incubator Pad for Apnea of Prematurity
NA trial testing SVS mattress in Apnea of Prematurity in 140 participants. Currently enrolling.
1 October 2026
Quick facts
| Lead sponsor | Tufts Medical Center |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 140 |
| Start date | 6 February 2025 |
| Primary completion | 1 October 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- SVS mattress
Conditions studied
- Apnea of Prematurity — all drugs for Apnea of Prematurity →
Sponsor
Tufts Medical Center
Who can join
Adults 0 Days to 3 Months, any sex, with Apnea of Prematurity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06374147
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of SVS mattress
Trials testing the same drug.
- NCT03881553 — Interventions to Help Infants Recover in the Hospital · NA · terminated
Other recruiting trials for Apnea of Prematurity
Currently open trials in the same condition.
- NCT07396103 — Efficacy of PIMUN by Reducing Intermittent Hypoxia Events · NA · recruiting
- NCT06905496 — Apnea of Prematurity Results in Respiratory Distress and Cyanosis. Caffeine Citrate Can Treat It. · Phase 1 · active not recruiting
- NCT05196646 — Detection of CardioRespiratory Events Using Acoustic Monitoring in Preterm Infants on CPAP · active not recruiting
- NCT04430790 — Doxapram Therapy in Preterm Infants (DOXA Trial) · Phase 3 · recruiting
Other Tufts Medical Center trials
Trials by the same sponsor.
- NCT07386041 — Lung Ultrasound-Guided Respiratory Management in Infants · NA · not yet recruiting
- NCT06016517 — Application of the Personalized N-of-1 Trial Design in Patients With Rheumatoid Arthritis · not yet recruiting
- NCT07473713 — Veverimer to Decrease Net Acid Excretion and Bone Resorption in Adults With Osteopenia · Phase 1 · recruiting
- NCT07097168 — Using WHOOP Fitness Band to Measure Heart Health Variability Before and After Surgery · withdrawn
- NCT06384898 — Remote Tai Chi for Knee Osteoarthritis · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06374147 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tufts Medical Center
- Last refreshed: 7 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06374147.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing