"Prapela® SVS Incubator Pad for Apnea of Prematurity (NCT06374147)
"Prapela® SVS Incubator Pad: a Cost-effective Stochastic Vibrotactile Device to Improve the Clinical Course of Infants with Apnea of Prematurity."
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama — Birmingham, Alabama
Age range: 0 Days to 3 Months
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (2 Sites)
- University of Alabama — Birmingham, Alabama
- Tufts Medical Center — Boston, Massachusetts
📞 Contact the Study Coordinator
Phone: (617) 636-5322
Email: rachana.singh1@tuftsmedicine.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Apnea of Prematurity
- Caffeine Use in the Management of Preterm Infants — Orange, California
- Detection of CardioRespiratory Events Using Acoustic Monitoring in Preterm Infants on CPAP — Montreal, Quebec
- Doxapram Therapy in Preterm Infants (DOXA Trial) — Brussels, Avenaue Hippocrate 10
- The Effect of Womb Recordings on Maturation of Respiratory Control in Preterm Infants — Cleveland, Ohio
- Detection of Respiratory Events Using Acoustic Monitoring in Extremely Preterm Infants — Montreal, Quebec
Explore by condition: All Apnea of Prematurity clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.