Dino Egg in Neonatal Intensive Care Unit
| Status: | Withdrawn |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/9/2019 |
| Start Date: | July 1, 2019 |
| End Date: | January 1, 2024 |
Dino Egg Mother's Voice Exposure and Speech Sound Processing in Neonatal Intensive Care Unit Infants
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.
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.
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).
We found this trial at
1
site
700 Childrens Drive
Columbus, Ohio 43205
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: Nathalie L Maitre, MD,PHD
Phone: 614-722-4428
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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