Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-25 @ 3:33 AM
NCT ID:
NCT03447405
Brief Summary:
Dino EGG mother's voice exposure and multisensory processing in Neonatal Intensive Care Unit infants.
This is a 2 phase prospective comparative effectiveness trial of our parents' voice intervention with 290 hospitalized preterm infants.
As a part of a previous project, an early technology development award from the Nationwide Children's Hospital (NCH) Technology Office allowed us to develop 10 functioning prototypes of the DINO EGG speakers, a NICU-safe and developmentally appropriate music player that delivers parent's voice to the bedside of NICU infants. The device passed NCH NICU-safe products committee and has been used in the clinical setting delivering clinical music therapy services (available at bedside to play parents' voice).
The first phase of the current study is to test an updated prototype version of the device that replicates a previously FDA (and NCH NICU-safe products) proved device called Pacifier Activated Lullaby (PAL), used and described in IRB15-01035, but being discontinued by the company. The discontinuation is not due to safety or health benefits concerns. Therefore, no device available on the market currently exists to accomplish NICU parents' voice delivery in a consistent and safe manner, the investigators modified a 510K-approved feeding device that is no longer available and whose intellectual property rights have expired. The device's air displacement sensor, which fits into a standard NICU pacifier, allowed the investigators to deliver processed and developmentally appropriate recordings of parent's voice, contingent upon the infant producing effort to receive it. Intellectual property rights were filed for the modifications and use process through the technology transfer and legal office at NCH.
Therefore, phase I will test the usability of the device (safety for the NICU was confirmed), not the effectiveness of the parents' voice delivery for the infant. Parent and nursing questionnaires about the importance of the device availability and its usability will be collected from parents and Registered Nurse (RN) staff that choose to provide the feedback.
Study:
NCT03447405
Study Brief:
Protocol Section:
NCT03447405