SVS Incubator Pad for Apnea of Prematurity
(Prapela AOP Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Tufts Medical Center
Must be taking: Caffeine citrate
Disqualifiers: Intubation, Major congenital malformations, others
Stay on Your Current Meds
No Placebo Group
Trial Summary
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.
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.
12345How 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.
12367Eligibility 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
+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)
+2 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
University of AlabamaBirmingham, AL
Tufts Medical CenterBoston, MA
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Who Is Running the Clinical Trial?
Tufts Medical CenterLead Sponsor
University of Alabama at BirminghamCollaborator
References
The effect of vertical pulsating stimulation on apnea of prematurity. [2004]Placing preterm infants suffering idiopathic apnea of prematurity on the VPS had an effect on the infants' respiratory effort and achieved a reduction in the number of apneic episodes secondary to central and mixed apnea. However, VPS offered no benefits in the reduction of obstructive apnea in this study population. Because central apnea has been reported as the predominant type of apnea and VPS is a nontoxic, noninvasive, and easy-to-implement method of alleviating central and mixed apnea types, it seems prudent to give VPS which has the stimulus characteristics to preterm infants experiencing apnea of prematurity before other treatment modalities currently in use are tried. Further studies are warranted to determine if VPS is effective in a continuous long-term treatment for apnea of prematurity, for example, until the end of apnea.
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, a common disorder, can severely compromise an infant's condition unless correctly diagnosed and treated. Infants with a history of apnea of prematurity can be discharged home but then be rehospitalized for an apneic event, an apparent life-threatening event, or sudden infant death syndrome. The definition of a clinically significant cardiopulmonary event, such events' documentation, and the treatment approach were standardized, and discharge criteria were refined.
Apnea of prematurity. Comparative therapeutic effects of cutaneous stimulation and nasal continuous positive airway pressure. [2019]It has been suggested that idiopathic apnea of prematurity is related to hypoxia from pulmonary instability or an immaturity of central respiratory control mechanisms. To explore these hypotheses, 18 preterm infants were studied to examine the therapeutic effects of prophylactic cutaneous stimulation (6) and continuous positive airway pressure(12). The frequency of apnea using each procedure was reduced by 35 and 69 percent, respectively. These findings constitute the basis for new therapeutic measures for treatment of idiopathic neonatal apnea.
[APNEA OF PREMATURITY - PATHOPHYSIOLOGY, TREATMENT & PROGNOSIS]. [2020]Apnea of prematurity affects the majority of infants born before 34 weeks of complete gestation. Significant recurrent apnea of prematurity is associated with both short and long term complications and is a risk factor for increased mortality and neurodevelopmental disability. The current review discusses the recent advances in the understanding of the pathophysiology of apnea of prematurity, as well as the clinical questions relevant to physicians and staff treating infants with apnea of prematurity. Finally, we discuss monitoring and discharge decisions, and present recommendations following discharge from the neonatal intensive care unit.
Prophylactic Oropharyngeal Surfactant for Preterm Newborns at Birth: A Randomized Clinical Trial. [2023]Preterm newborns at risk of respiratory distress syndrome are supported with continuous positive airway pressure (CPAP). Many newborns worsen despite CPAP and are intubated for surfactant administration, an effective therapy for treatment of respiratory distress syndrome. Endotracheal intubation is associated with adverse effects. Pharyngeal administration of surfactant to preterm animals and humans has been reported as an alternative.
Apnea in the premature infant: an overview of causes and treatment. [2016]In summary, apnea of prematurity is both a primary and a secondary disorder--a reflection of CNS immaturity as well as a response to an underlying problem. Premature infants are extremely vulnerable to developing apnea. Close monitoring by the nursing staff and early detection and treatment of apnea and its associated disorders are essential to insure optimal growth and development of these tiny infants.
A primer on Apnea of prematurity. [2019]Apnea, the cessation of respiratory airflow, can begin in many preterm infants in the first week of life and can last until the day of discharge or beyond. This article provides an overview of the complex anatomic, physiological, and developmental mechanisms related to immaturity of both the central nervous system and musculature of the pulmonary system, that contribute to apnea of prematurity. Apnea of prematurity is a diagnosis of exclusion; an array of other conditions and stimuli can also cause apnea, including infections, pulmonary disease, and intracranial pathology. The standard clinical management of apnea, including cutaneous stimulation, methylxanthine therapy, and continuous positive airway pressure or ventilatory support, are discussed as well as newer investigational therapies, such as olfactory stimulation. Emerging evidence on the long-term neurodevelopmental impact of apnea is reviewed. Nursing measures to prevent and manage apnea are reviewed with an emphasis on parent education and preparation for discharge. Apnea resolves in most preterm infants as they approach term corrected gestational age; however, if it does not, options include continued hospitalization or, for infants with stable apnea, discharge with a home apnea monitor.