Development of a Therapeutic Device to Improve Speech Sound Differentiation in Preterm Infants
Recruiting
N/A
Interventional Study
Premature Birth
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 32 Weeks – 35 Weeks
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 203 (estimated)
- Sponsor
- Thrive Neuromedical, LLC · Industry
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About This Trial
The goal of this clinical study is to test a new, novel medical device designed to improve speech sound differentiation among hospitalized preterm infants. The device is designed to be used at an age equivalent to 32 weeks of gestation or older and to integrate readily into clinical practice for use by nurses and therapists staffing Level II to Level IV NICUs. Preterm born infants are at high risk…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* CGA 32 0/7-35 0/7 weeks at study start, and GA 35 0/7 weeks at birth
Exclusion Criteria:
* Ventilation using an endotracheal tube, major congenital malformations, family history of genetic hearing loss, and use of sedative/seizure medications (medications potentially masking…
Contacts