Novel incubator pad for treating apnea in premature infants
Official title: "Prapela® SVS Incubator Pad: a Cost-effective Stochastic Vibrotactile Device to Improve the Clinical Course of Infants with Apnea of Prematurity."
Run by Tufts Medical Center · NCT06374147 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 0 Days to 3 Months |
| Sex | All |
| Enrollment | 140 (estimated) |
| Sponsor | Tufts Medical Center Academic / other |
| Locations | 2 sites (Birmingham, Alabama and 1 other locations) |
| Status | Recruiting |
| Started | February 6, 2025 |
| Main results expected | October 1, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | March 7, 2025 |
| Trial ID | NCT06374147 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients who are intubated or on mechanical ventilation, or those with major congenital malformations, will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies using similar vibrotactile stimulation approaches have shown promising results, indicating a potential for success in this novel application.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study tests a tiny wireless sensor system to monitor heart rate, oxygen, and temperature in extremely preterm babies in the NICU to see if it works safely without wires.
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Caffeine in pregnancy: how the mother and baby handle it during delivery
This study tests how caffeine is processed in pregnant people and how much reaches the baby when given shortly before delivery.
-
Detection of Respiratory Events in Extremely Preterm Infants Using Acoustic Monitoring
A new acoustic monitoring approach is being tested to detect breathing problems in very preterm babies to help NICU teams spot and manage apnea and related events.
-
PIMUN to reduce low-oxygen episodes in preterm infants
We will test whether PIMUN, a soft garment that gives gentle pulsatile dorsal stimulation, can reduce low-oxygen (SpO2 <90%) episodes in preterm infants born at 24–34 weeks who have apnea of prematurity.
-
Using EEG to time stopping caffeine in premature infants
This study will see if EEG brain recordings can help doctors decide when to stop caffeine treatment in preterm infants so apnea does not come back.
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Caffeine citrate after discharge for moderately preterm infants at risk of apnea
This trial tests whether continuing caffeine citrate after hospital discharge reduces apnea-related healthcare visits and improves development at 12 months in moderately preterm infants, compared to a placebo.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.