"Prapela® SVS Incubator Pad for Apnea of Prematurity
Recruiting
N/A
Interventional Study
Apnea of Prematurity
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 0 Days – 3 Months
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 140 (estimated)
- Sponsor
- Tufts Medical Center · Other
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About This Trial
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 …
Trial Locations
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Eligibility 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 with…
Contacts