"Prapela® SVS Incubator Pad for Apnea of Prematurity

Conditions

• Apnea of Prematurity

Eligibility Criteria

Sex

ALL

Age

0 Days - 3 Months

Healthy Volunteers

Not accepted

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

Study Details

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.

Key Dates

Start date

Feb 6, 2025

Status verified

Feb 2025

Primary completion

Oct 1, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

140 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 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.
• No Intervention: 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

Primary Outcome Measure

Change in apnea rate [ Time Frame: 7-28 days of intervention ]

Central Contacts

• Rachana Singh, MD, MS
  6176365322
  [email protected]
• John Konsin
  8337727352
  [email protected]

Locations (2)

Find similar trials in Birmingham, AL

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