140 Participants Needed

SVS Incubator Pad for Apnea of Prematurity

(Prapela AOP Trial)

Recruiting at 1 trial location
RS
JK
Overseen ByJohn Konsin
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Tufts Medical Center
Must be taking: Caffeine citrate
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the SVS Incubator Pad treatment for apnea of prematurity?

The research on vertical pulsating stimulation (VPS), which is similar to the SVS Incubator Pad, shows that it can reduce the number of apneic episodes in preterm infants by improving their breathing effort, particularly for central and mixed types of apnea.12345

How does the SVS Incubator Pad treatment for apnea of prematurity differ from other treatments?

The SVS Incubator Pad is unique because it likely uses a noninvasive method similar to vertical pulsating stimulation (VPS), which helps reduce central and mixed apnea episodes in preterm infants. This approach is different from standard treatments like cutaneous stimulation or continuous positive airway pressure, as it is easy to implement and non-toxic.12367

What is the purpose of this trial?

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.

Eligibility Criteria

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

I am taking caffeine citrate for my condition, as recommended by my doctor.
Gestational age between 22 weeks 0 days and 32 weeks 6 days
At least 4 clinically documented apnea events in the previous 24 hours
See 2 more

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)
See 2 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: SVS mattress armExperimental Treatment1 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: StandardActive Control1 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

Find a Clinic Near You

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+

Findings from Research

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.
The effect of vertical pulsating stimulation on apnea of prematurity.Jirapaet, K.[2004]
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.
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]
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.
Apnea of prematurity. Comparative therapeutic effects of cutaneous stimulation and nasal continuous positive airway pressure.Kattwinkel, J., Nearman, HS., Fanaroff, AA., et al.[2019]

References

The effect of vertical pulsating stimulation on apnea of prematurity. [2004]
Standardizing documentation and the clinical approach to apnea of prematurity reduces length of stay, improves staff satisfaction, and decreases hospital cost. [2022]
Apnea of prematurity. Comparative therapeutic effects of cutaneous stimulation and nasal continuous positive airway pressure. [2019]
[APNEA OF PREMATURITY - PATHOPHYSIOLOGY, TREATMENT & PROGNOSIS]. [2020]
Prophylactic Oropharyngeal Surfactant for Preterm Newborns at Birth: A Randomized Clinical Trial. [2023]
Apnea in the premature infant: an overview of causes and treatment. [2016]
A primer on Apnea of prematurity. [2019]
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