Premature BirthNCT03447405
Dino Egg in Neonatal Intensive Care Unit
A study testing Dino Egg in people with Premature Birth, run by Jonathan Slaughter at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 32 to 34 weeks
- Conditions the study is for
- Premature Birth
- What is being tested?
- Dino Egg
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Inclusion criteria will be Post Menstrual Age (PMA) 32 0/7-34 6/7.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: 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.
Read more
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.
- Conditions
- Premature Birth
- Being tested
- Dino Egg
- Keywords
- Music Therapy, NICU, Infants, multisensory processing
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dino EggDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Dino Egg Safety and useability | Experimental | 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. Receives: Device: Dino Egg |
| Standard of Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of the device through questionaires
We will confirm a larger scale that for preterm infants, standardized exposure to mother's voice with a contingent stimulus of non-nutritive sucking can improve the development of speech sound discrimination in the NICU. 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 RN staff that choose to provide the feedback.
Measured: Through end of study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start1 Jul 2019 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
Why it stopped: Grant not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonathan Slaughter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jonathan Slaughter, Nationwide Children's Hospital
- Investigators
- Nathalie L Maitre, MD,PHD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447405
- Sponsor's protocol ID
- IRB18-00012
- Status last verified
- Feb 2024
- First submitted
- 23 Jan 2018
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dino Egg Mother's Voice Exposure and Speech Sound Processing in Neonatal Intensive Care Unit Infants
- ClinicalTrials.gov ID
- NCT03447405
- Acronym / sponsor ID
- IRB18-00012
- Conditions
- Premature Birth
- Keywords
- Music Therapy, NICU, Infants, multisensory processing
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Grant not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jonathan SlaughterUniversity, hospital or other
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 27 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dino Egg Safety and useability | Experimental | Device: Dino EggTest 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. |
| Standard of Care | No intervention | – |
Who may qualify
- Ages
- 32 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Inclusion criteria will be Post Menstrual Age (PMA) 32 0/7-34 6/7.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dino EggDINO 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). | Device | Dino Egg Safety and useability |
Primary outcome
Usability of the device through questionaires
Time frame: Through end of study completion, an average of 1 year
We will confirm a larger scale that for preterm infants, standardized exposure to mother's voice with a contingent stimulus of non-nutritive sucking can improve the development of speech sound discrimination in the NICU. 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 RN staff that choose to provide the feedback.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie L Maitre, MD,PHD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dino Egg in people with Premature Birth, run by Jonathan Slaughter at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of the device through questionaires (time frame: Through end of study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024; AzTrials last refreshed its copy on 26 Oct 2026.