Clinical trial NCT03447405: Dino Egg in Neonatal Intensive Care Unit
Official title: Dino Egg Mother's Voice Exposure and Speech Sound Processing in Neonatal Intensive Care Unit Infants
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Premature Birth
Keywords: Music Therapy
NICU
Infants
multisensory processing
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2018-02-27
Enrollment: 0
Sex: ALL
Minimum age (years): 32
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 RN staff that choose to provide the feedback.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Usability of the device through questionaires
timeFrame: Through end of study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Nathalie L Maitre, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References: