WithdrawnNot Applicable

Dino Egg in Neonatal Intensive Care Unit

Stopped: Grant not funded

United States0Started 2019-07-01

Plain-language 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.

Who can participate

Age range

32 Weeks – 34 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Inclusion criteria will be Post Menstrual Age (PMA) 32 0/7-34 6/7. Exclusion Criteria: * Ventilation using an endotracheal tube * Major congenital malformations * Family history of genetic hearing loss * Use of sedatives or seizure medications * Presence of severe neural injury on neuroimaging (intraventricular hemorrhage grade II or IV, periventricular leukomalacia, cerebellar hemorrhage, ischemic or thrombotic injury) * Presence of systemic inflammatory conditions (history of necrotizing enterocolitis Bell's stage IIA or above or culture-documented sepsis or meningitis).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Usability of the device through questionaires

Timeframe: Through end of study completion, an average of 1 year

Trial details

NCT IDNCT03447405

SponsorJonathan Slaughter

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-01

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