SVS Incubator Pad for Apnea of Prematurity

(Prapela AOP Trial)

Recruiting at 1 trial location

Overseen By John Konsin

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Tufts Medical Center

Must be taking: Caffeine citrate

Disqualifiers: Intubation, Major congenital malformations, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 7-28 days

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new hospital incubator pad, the SVS Incubator Pad, which uses gentle vibrations to help manage apnea of prematurity (AOP). This condition causes preterm babies to stop breathing briefly. The trial aims to determine if this vibrating pad can complement the current treatment, Caffeine Citrate, to reduce the need for breathing support and shorten hospital stays. Babies born between 22 to 32 weeks who have experienced at least four apnea episodes in the past day may qualify. The trial will compare babies using the vibrating pad with those receiving standard care to assess its effectiveness and safety.

As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance care for preterm infants.

Will I have to stop taking my current medications?

The trial does not specify if participants must stop taking their current medications. However, it mentions that participants should be on a certain dose of Caffeine Citrate, which suggests that continuing this medication is required.

What prior data suggests that the SVS Incubator Pad is safe for preterm infants?

Research shows that the SVS Incubator Pad is a new, gentle device tested for safety and effectiveness in helping premature babies with apnea of prematurity (AOP), a condition that disrupts regular breathing. The SVS Pad uses soft vibrations to assist with breathing. Current studies are evaluating its safety for use in babies. Although specific safety data from human trials is not yet available, the device's gentle nature suggests it might be well-tolerated. It is important to note that the SVS Pad is not yet approved for this use, and more research is needed to fully understand its safety in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SVS Incubator Pad for treating apnea of prematurity because it offers a novel approach by using gentle vibration to stimulate the infant's respiratory system. Unlike standard treatments like caffeine citrate, which stimulate the central nervous system chemically, this pad provides continuous mechanical stimulation. This non-invasive method could potentially reduce the reliance on medication, offering a safer and more comfortable option for newborns. Additionally, the pad's ability to automatically adjust and cease treatment once the infant is stable could streamline care and reduce intervention times.

What evidence suggests that the SVS Incubator Pad is effective for apnea of prematurity?

Research has shown that the SVS Incubator Pad, which participants in this trial may receive, can effectively treat apnea of prematurity (AOP), a condition where premature babies stop breathing briefly. Early results suggest that this vibrating pad reduces the need for breathing support in these infants. In this trial, the SVS Incubator Pad will be used alongside Caffeine Citrate, the current standard treatment, and may help shorten hospital stays. The FDA has recognized the pad as a Breakthrough Device, highlighting its promising potential. This non-invasive method could offer a new way to manage AOP in newborns. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for preterm infants born between 22 and nearly 33 weeks, experiencing at least four apnea events in the last day. They must be on a stable dose of Caffeine Citrate and may use certain respiratory supports. Infants with major birth defects (except small hernia or patent ductus arteriosus) or other breathing disorders, or those needing more intensive respiratory support are excluded.

Inclusion Criteria

Gestational age between 22 weeks 0 days and 32 weeks 6 days

I am taking caffeine citrate for my condition, as recommended by my doctor.

At least 4 clinically documented apnea events in the previous 24 hours

Exclusion Criteria

I am on a breathing machine or need help to breathe.

Refusal or withdrawal of consent

Major congenital malformations (not including patent ductus arteriosus, small hernia)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive standard therapy with caffeine citrate and either an inert or active SVS incubator pad

7-28 days

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

Observation

Clinicians observe patients for 24 hours after treatment ends to monitor for return of apnea

1 day

What Are the Treatments Tested in This Trial?

Interventions

• SVS Incubator Pad

Trial Overview The study is testing an innovative incubator pad called Prapela® SVS that uses gentle vibrations to help manage apnea in premature babies. It's being evaluated as an additional treatment alongside the standard caffeine therapy to potentially reduce the need for respiratory support and hospital stay duration.

How Is the Trial Designed?

Group I: SVS mattress arm Experimental Treatment 1 Intervention

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 II: Standard Active Control 1 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

Who Is Running the Clinical Trial?

Tufts Medical Center

Lead Sponsor

Trials

264

Recruited

264,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

A standardized approach to diagnosing and treating apnea of prematurity in infants significantly reduced hospital stay lengths, with the standard-approach group experiencing no discharge delays compared to 35% in the prestandard group.

The implementation of this standardization not only improved discharge safety—resulting in no readmissions for apnea of prematurity in the standard group—but also saved over $58,000 in hospital costs by avoiding unnecessary hospital days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardizing documentation and the clinical approach to apnea of prematurity reduces length of stay, improves staff satisfaction, and decreases hospital cost. Butler, TJ., Firestone, KS., Grow, JL., et al.[2022]

Apnea of prematurity is a common condition affecting most infants born before 34 weeks of gestation, leading to serious short- and long-term complications, including increased mortality and neurodevelopmental disabilities.

Recent advances in understanding the causes of apnea of prematurity are crucial for improving monitoring and discharge decisions for affected infants, emphasizing the need for careful management in neonatal intensive care units.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[APNEA OF PREMATURITY - PATHOPHYSIOLOGY, TREATMENT & PROGNOSIS]. Gileles-Hillel, A., Erlichman, I., Reiter, J., et al.[2020]

In a clinical trial involving 251 preterm newborns, administering prophylactic oropharyngeal surfactant at birth did not significantly reduce the rate of intubation for respiratory failure compared to those receiving only CPAP.

The study found that more newborns in the oropharyngeal surfactant group developed pneumothorax, suggesting potential safety concerns with this method, and indicating it should not be routinely used in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prophylactic Oropharyngeal Surfactant for Preterm Newborns at Birth: A Randomized Clinical Trial. Murphy, MC., Miletin, J., Klingenberg, C., et al.[2023]

Using a Vibratory Positive Airway Pressure (VPS) method for preterm infants with idiopathic apnea of prematurity significantly reduced the number of central and mixed apnea episodes, which are the most common types in this population.

VPS is a safe, noninvasive, and easy-to-use treatment option, but it did not show benefits for obstructive apnea, suggesting it should be considered before other treatments for central apnea in preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of vertical pulsating stimulation on apnea of prematurity. Jirapaet, K.[2004]

Apnea of prematurity is a common condition in premature infants, caused by both central nervous system immaturity and other underlying issues, making these infants particularly susceptible to breathing problems.

Close monitoring and prompt treatment of apnea and related disorders are crucial for ensuring the healthy growth and development of premature infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apnea in the premature infant: an overview of causes and treatment. Sham, B., Messerly, AM.[2016]

In a study of 18 preterm infants, continuous positive airway pressure (CPAP) was found to be more effective than prophylactic cutaneous stimulation in reducing the frequency of apnea, with a 69% reduction compared to a 35% reduction for cutaneous stimulation.

These results suggest that CPAP could be a promising new therapeutic approach for treating idiopathic apnea of prematurity, which is thought to be linked to hypoxia and immature respiratory control mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apnea of prematurity. Comparative therapeutic effects of cutaneous stimulation and nasal continuous positive airway pressure. Kattwinkel, J., Nearman, HS., Fanaroff, AA., et al.[2019]

Apnea of prematurity is a common condition in preterm infants, often starting in the first week of life and linked to the immaturity of their central nervous and pulmonary systems, but it typically resolves as infants reach their corrected gestational age.

Standard management strategies include cutaneous stimulation, methylxanthine therapy, and ventilatory support, while newer approaches like olfactory stimulation are being explored; education for parents is crucial for effective management and preparation for discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A primer on Apnea of prematurity. Stokowski, LA.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06374147

Prapela® SVS Incubator Pad for Apnea of Prematurity 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 ...

2. reporter.nih.gov reporter.nih.gov/project-details/10576754

Prapela® SVS incubator pad: A cost-effective stochastic ... Prapela® SVS incubator pad: A cost-effective stochastic vibrotactile device to improve the clinical course of infants with apnea of prematurity. Project ...

3. prapela.com prapela.com/research-grants

Research "Prapela® SVS incubator pad: A cost-effective stochastic vibrotactile device to improve the clinical course of infants with apnea of prematurity." This Fast- ...

4. withpower.com withpower.com/trial/phase-premature-birth-4-2024-b48bb

SVS Incubator Pad for Apnea of Prematurity 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 ...

5. prapela.com prapela.com/general-1

Apnea of Prematurity FDA Breakthrough Designation. On November 4, 2022 the FDA awarded Prapela's Incubator pad and Radiant Warmer with Breakthrough Device Designation. As an ...

6. sbir.gov sbir.gov/portfolio/1311761

Company Prapela® SVS incubator pad: A cost-effective stochastic vibrotactile device to improve the clinical course of infants with apnea of prematurity.

7. nida.nih.gov nida.nih.gov/funding/small-business-innovation-research-sbir-technology-transfer-sttr-programs/success-stories

SBIR/STTR Success Stories | National Institute on Drug ... Prapela® SVS incubator pad: A cost-effective stochastic vibrotactile device to improve the clinical course of infants with apnea of prematurity ...