"Prapela® SVS Incubator Pad for Apnea of Prematurity

NCT ID: NCT06374147

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-06
• Study Completion Date: 2026-12-31

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.

Detailed 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 that will provide a complementary treatment and the first improvement in the clinical management of apnea of prematurity (AOP) in over 20 years. Defined as cessation of breathing for 20 seconds or longer or a shorter pause accompanied by hypoxemia, AOP is a major morbidity among preterm infants and a significant healthcare burden. AOP affects 70% of all early preterm births (<34 weeks gestational age) and nearly all at ≤ 28 weeks' gestation. In the United States in 2020, the total annual direct costs associated with AOP exceeded $12 billion. While there is no consensus for treating AOP, common interventions include positional techniques, caffeine citrate, manual tactile stimulation, and supplemental oxygen for hypoxemia. Caffeine citrate is the first line of therapy as it decreases apneic episodes and reduces the need for assisted ventilation. At recommended doses, caffeine has been proven safe and effective. However, in the sole trial supporting its FDA clearance, a majority of newborns treated with caffeine citrate continued to experience apnea events. In 2015, a clinical study using a stochastic vibrotactile stimulation (SVS) investigational device reported a 50% reduction in the number of apnea events. Prapela exclusively licensed the SVS technology of the investigational device and has demonstrated technical feasibility replicating the clinically critical stimulation in prototype incubator pads. The broad objective of this SBIR Fast-Track application is to generate the data and documentation necessary for FDA marketing clearance of a novel device to reduce apnea events in preterm newborns. To accomplish this objective, Prapela proposes four Specific Aims: 1) complete development of the SVS incubator pad, 2) demonstrate the safety of the device, 3) determine the clinical efficacy of the SVS incubator pad as an adjunctive therapy to concurrent pharmacological treatment in newborns with AOP, and 4) document the risk/benefit assessment of the device from clinicians caring for AOP patients. Efficacy will be established through a masked, randomized clinical trial with newborns of <33 weeks gestational age, with postmenstrual age (PMA) of <38 weeks at the time of enrollment. The control group will receive standard care only with caffeine citrate and respiratory support and an inert SVS device, while the intervention group will receive standard therapy concurrent with the Prapela SVS device. The primary outcome measure will be the mean number of apnea events in the three days after study entry, with a reduction in apnea events of 30% or more considered clinically significant. Questionnaires administered at the end of each experimental period to the clinicians present on the final shift will capture the risk/benefit assessment. The successful completion of the project will provide the data and documentation necessary for FDA marketing clearance and commercialization of our SVS incubator pad as a purpose-built device to improve clinical outcomes of preterm infants with AOP

Conditions

Apnea of Prematurity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SVS mattress arm

The intervention group will receive standard therapy ( Caffeine Citrate) plus continuous SVS stimulation using the Prapela SVS incubator pad. 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.

Group Type: EXPERIMENTAL

SVS mattress

Intervention Type: DEVICE

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

Standard

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

Tufts Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Alabama

Birmingham, Alabama, United States

Site Status: RECRUITING

Tufts Medical Center

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rachana Singh, MD, MS

Role: CONTACT

rachana.singh1@tuftsmedicine.org

6176365322

John Konsin

Role: CONTACT

johnkonsin@prapela.com

8337727352

Facility Contacts

Namasivayam Ambalavanan, MD

Role: primary

nambalav@uabmc.edu

800-822-8816

Rachana Singh, MD MS

Role: primary

rachana.singh1@tuftsmedicine.org

617-636-5322

Other Identifiers

STUDY00004467

Identifier Type: -

Identifier Source: org_study_id