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New treatment option for Apnea of Prematurity
Official title "Prapela® SVS Incubator Pad for Apnea of Prematurity
ClinicalTrials.gov ID: NCT06374147
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 3
You may be able to join 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...
You likely can't join if
- Intubation and mechanical ventilation, or non-invasive positive pressure ventilation (NIPPV) if not intubated, or pressure support breaths while on...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Boston, Massachusetts, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 days to 3 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.