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

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. ^{1 2 3 4 5}

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. ^{1 2 3 6 7}

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

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

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

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+

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

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]

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 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]

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]

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]

References

1. Thailand pubmed.ncbi.nlm.nih.gov

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

2. Netherlands 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Apnea of prematurity. Comparative therapeutic effects of cutaneous stimulation and nasal continuous positive airway pressure. [2019]

4. Israel pubmed.ncbi.nlm.nih.gov

[APNEA OF PREMATURITY - PATHOPHYSIOLOGY, TREATMENT & PROGNOSIS]. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Prophylactic Oropharyngeal Surfactant for Preterm Newborns at Birth: A Randomized Clinical Trial. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Apnea in the premature infant: an overview of causes and treatment. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

A primer on Apnea of prematurity. [2019]