"Prapela® SVS Incubator Pad for Apnea of Prematurity

NCT06374147 | Recruiting DMC FDA Device

• 1 other identifier: STUDY00004467
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

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.

Conditions

Apnea of Prematurity

Outcome Measures

Primary Outcomes (1)

• Change in apnea rate

  The primary outcome is a single continuous measure, the change in (AOP), days 0-12 inclusive, from the baseline apneic rate assessed during the 24-hour run-in period, when all infants are treated on standard CC dosing prior to randomization on day 0.

  7-28 days of intervention

Secondary Outcomes (4)

• Secondary Outcome measure

  0 to12 days and 0 to28 days

• Secondary Outcome measure

  0 to12 days and 0 to28 days

• Secondary Outcome measure

  0 to12 days and 0 to28 days

• Secondary Outcome measures

  0 to12 days and 0 to28 days

Study Arms (2)

SVS mattress arm

EXPERIMENTAL

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.

Device: SVS mattress

Standard

NO INTERVENTION

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

Interventions

SVS mattress 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

SVS mattress arm

Eligibility Criteria

• Age: 0 Days - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts Medical Center: lead
• University of Alabama at Birmingham: collaborator

Study Sites (2)

University of Alabama

Birmingham, Alabama, 35233, United States

RECRUITING

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

MeSH Terms

Conditions

Apnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Rachana Singh, MD, MS

CONTACT

6176365322; rachana.singh1@tuftsmedicine.org

John Konsin

CONTACT

8337727352; johnkonsin@prapela.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 18, 2024
• Study Start: February 6, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)