Novel incubator pad for treating apnea in premature infants
"Prapela® SVS Incubator Pad: a Cost-effective Stochastic Vibrotactile Device to Improve the Clinical Course of Infants with Apnea of Prematurity."
This study is testing a new incubator pad that uses gentle vibrations to help preterm infants with apnea breathe better and need less medical support.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 0 Days to 3 Months |
| Sex | All |
| Sponsor | Tufts Medical Center Academic / other |
| Locations | 2 sites (Birmingham, Alabama and 1 other locations) |
| Trial ID | NCT06374147 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and evaluate the safety and efficacy of a new hospital incubator pad that uses stochastic vibrotactile stimulation (SVS) to treat apnea of prematurity (AOP) in preterm infants. AOP is a common condition affecting many preterm infants, and current treatments primarily involve caffeine citrate. The SVS pad is designed to be a non-invasive adjunct therapy that could potentially reduce the frequency of apnea events and shorten the duration of respiratory support needed. The study will assess the clinical risk/benefit of this innovative approach compared to existing treatments.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants between 22 weeks and 32 weeks 6 days gestational age who have experienced multiple apnea events.
Not a fit: Patients who are intubated or on mechanical ventilation, or those with major congenital malformations, will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of apnea of prematurity, leading to better outcomes for preterm infants.
How similar studies have performed: Previous studies using similar vibrotactile stimulation approaches have shown promising results, indicating a potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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
Where this trial is running
Birmingham, Alabama and 1 other locations
- University of Alabama — Birmingham, Alabama, United States (Recruiting)
- Tufts Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Rachana Singh, MD, MS
- Email: rachana.singh1@tuftsmedicine.org
- Phone: 6176365322
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.