Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374147
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-16
Brief Title:
Prapela SVS Incubator Pad for Apnea of Prematurity
Sponsor:
Tufts Medical Center
Organization:
Tufts Medical Center
Study Overview
Official Title:
Prapela SVS Incubator Pad A Cost-effective Stochastic Vibrotactile Device to Improve the Clinical Course of Infants With Apnea of Prematurity
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Prapela AOP
Brief Summary:
The study proposes to complete the development of and then establish the safety efficacy and clinical riskbenefit 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
Detailed Description:
The study proposes to complete the development of and then establish the safety efficacy and clinical riskbenefit of a novel hospital incubator pad that will provide a complementary treatment and the first improvement in the clinical management of apnea of prematurity AOP in over 20 years Defined as cessation of breathing for 20 seconds or longer or a shorter pause accompanied by hypoxemia AOP is a major morbidity among preterm infants and a significant healthcare burden AOP affects 70 of all early preterm births 34 weeks gestational age and nearly all at 28 weeks gestation In the United States in 2020 the total annual direct costs associated with AOP exceeded 12 billion While there is no consensus for treating AOP common interventions include positional techniques caffeine citrate manual tactile stimulation and supplemental oxygen for hypoxemia Caffeine citrate is the first line of therapy as it decreases apneic episodes and reduces the need for assisted ventilation At recommended doses caffeine has been proven safe and effective However in the sole trial supporting its FDA clearance a majority of newborns treated with caffeine citrate continued to experience apnea events In 2015 a clinical study using a stochastic vibrotactile stimulation SVS investigational device reported a 50 reduction in the number of apnea events Prapela exclusively licensed the SVS technology of the investigational device and has demonstrated technical feasibility replicating the clinically critical stimulation in prototype incubator pads The broad objective of this SBIR Fast-Track application is to generate the data and documentation necessary for FDA marketing clearance of a novel device to reduce apnea events in preterm newborns To accomplish this objective Prapela proposes four Specific Aims 1 complete development of the SVS incubator pad 2 demonstrate the safety of the device 3 determine the clinical efficacy of the SVS incubator pad as an adjunctive therapy to concurrent pharmacological treatment in newborns with AOP and 4 document the riskbenefit assessment of the device from clinicians caring for AOP patients Efficacy will be established through a masked randomized clinical trial with newborns of 33 weeks gestational age with postmenstrual age PMA of 38 weeks at the time of enrollment The control group will receive standard care only with caffeine citrate and respiratory support and an inert SVS device while the intervention group will receive standard therapy concurrent with the Prapela SVS device The primary outcome measure will be the mean number of apnea events in the three days after study entry with a reduction in apnea events of 30 or more considered clinically significant Questionnaires administered at the end of each experimental period to the clinicians present on the final shift will capture the riskbenefit assessment The successful completion of the project will provide the data and documentation necessary for FDA marketing clearance and commercialization of our SVS incubator pad as a purpose-built device to improve clinical outcomes of preterm infants with AOP
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None