What this study is
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.
What's being tested
- SVS mattress
Intervention · DEVICE
The intervention group will receive standard therapy plus continuous SVS stimulation using the Prapela SVS incubator pad. 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. 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. At 1 and 2 years of age, parents will be contacted for a brief telephone follow up survey to assess neurological development
Study details
- Official title
- "Prapela® SVS Incubator Pad: a Cost-effective Stochastic Vibrotactile Device to Improve the Clinical Course of Infants with Apnea of Prematurity."
- Sponsor
- Tufts Medical Center
- Conditions
- Apnea of Prematurity
- Enrolling
- 140 people
- Starts
- 2025-02-06
- Est. completion
- 2026-12-31
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 0 Days – 3 MonthsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 22 week 0 days-32 weeks 6 days gestational age (preterm)
- Either sex
- Single birth
- At least 4 clinically documented apnea events in the previous 24 hours
- Caffeine citrate at least 5 mg/kg/day dosing, with or without respiratory support oxygen, nasal cannula, or CPAP without and added rate or pressure support, if considered necessary by the clinical team)
You can't join if
- Intubation and mechanical ventilation, or non-invasive positive pressure ventilation (NIPPV) if not intubated, or pressure support breaths while on CPAP.
- Refusal or withdrawal of consent
- Major congenital malformations (not including patent ductus arteriosus, small hernia)
- Known disorder of breathing other than apnea of prematurity (e.g., congenital central hypoventilation syndrome, laryngotracheomalacia)
- Caffeine citrate dosing exceeding FDA recommended dosing in the first 24 hours, if deemed necessary by the clinical team
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openUniversity of Alabama
Birmingham, Alabama, United States
- Namasivayam Ambalavanan, MD · Contact800-822-8816nambalav@uabmc.edu
RecruitingTufts Medical Center
Boston, Massachusetts, United States
- Rachana Singh, MD MS · Contact617-636-5322rachana.singh1@tuftsmedicine.org
Recruiting
Study team
Sponsor
Tufts Medical Center
Study ID STUDY00004467
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.