Hearing Impairment
Conditions
Brief summary
Before they are born, babies are protected from hearing very loud noises by their mother's bodies. After delivery, they are exposed to many loud noises that are potentially harmful. These noises happen in the neonatal intensive care unit (NICU). The purpose of this research project is to test the fit and the ease-of-use of a new device that may protect infant's hearing in the NICU.
Detailed description
Despite the best efforts of Neonatal Intensive Care Unit (NICU) caregivers, vulnerable and fragile NICU patients are frequently exposed to noxious levels of noise from monitoring and respiratory equipment alarms, as well as from routine NICU care practices. Particularly detrimental to sleep and auditory development are patient exposures to high frequency noises that are specifically designed to alert NICU caregivers to important changes in patient status. This pilot study will help evaluate the fit, ergonomic design and the ease-of-use of a novel hearing protection system (special ear-muffs along with a unique attachment mechanism) specifically designed top diminish the transmission of high frequency noises to patients within the NICU, while allowing some transmission of low frequency sounds, such as a mother's voice.
Interventions
DEVICENEATCAP
Neonates will be sized and fitted to wear the non-invasive novel hearing protection device over a set period of time in the NICU. Vitals will be monitored.
Sponsors
Michael Balsan, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Hours to 2 Weeks
Healthy volunteers
No
Inclusion criteria
* Neonate admitted to the Neonatal Intensive Care Unit * Age greater than 12 hours and less than 2 weeks * Informed consent from the parent(s)
Exclusion criteria
* Significant cranial trauma noted on admission * Congenital anomalies of the head and/or neck * Hemodynamic instability requiring pharmacologic intervention * Recommendation by the attending neonatologist not to enroll the patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Skin Erythema After Device Application | Skin erythema was evaluated at the time of device removal after 1 hour of application in phase #1 and after 3 daily 8 hour periods of application in phase #2. | Skin will be assessed for adverse effects such as any device-related adverse events, including evidence of skin redness, rash and/or bruising or discomfort at the site of device application. Skin erythema was described as none, mild, moderate or severe as evaluated by the NICU nursing staff. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Specific Responses to the Ease of Use Questionnaire for NICU Staff. | After 1 hour in phase #1 / After 3 x 8 hours in phase #2 | A \>80% positive response to a multi-question Ease-of-Use Questionnaire completed by the participating NICU staff. Ease-of-Use Questionnaire constructed on a 5 point Likert Scale: 1 = Strongly Disagree, 2 = Disagree, 3 = Neutral, 4 = Agree, 5 = Strongly Agree that the device was easy-to-use. Phase #1 consists of 25 data points. Phase #2 consists of 25 data points. Evaluations were obtained after device removal in both phases. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from admissions to the neonatal intensive care unit (NICU) in two phases. In phase #1 of the study 25 infants were recruited for participation and 25 infants completed the protocol. In phase #2 of the study 30 additional infants were recruited, with 25 infants completing the protocol. The total number studied was 50.
Participants by arm
| Arm | Count |
|---|---|
| Phase #1 Infants recruited in phase #1 had the device placed for 1 hour, with recordings of vital signs before and after devise placement. | 25 |
| Phase #2 Infants recruited in phase #2 had the device placed for 8 hour periods on three consecutive days with vital signs recorded before, during and after device placements. | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Discharged from NICU prior to completion | 0 | 4 |
| Overall Study | Withdrawal by parent | 0 | 1 |
Baseline characteristics
| Characteristic | Phase #1 | Phase #2 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 25 Participants | 25 Participants | 50 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Birth Weight | 2.6 kilograms STANDARD_DEVIATION 0.84 | 2.3 kilograms STANDARD_DEVIATION 0.94 | 2.5 kilograms STANDARD_DEVIATION 0.9 |
| Gestational Age at Birth | 36.6 Weeks STANDARD_DEVIATION 3.29 | 34.8 Weeks STANDARD_DEVIATION 3.87 | 35.7 Weeks STANDARD_DEVIATION 3.7 |
| Head Circumference | 32.3 centimeters STANDARD_DEVIATION 3.03 | 31.4 centimeters STANDARD_DEVIATION 3.66 | 31.8 centimeters STANDARD_DEVIATION 3.4 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 10 Participants | 8 Participants | 18 Participants |
| Sex: Female, Male Male | 15 Participants | 17 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 1 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Number of Participants With Skin Erythema After Device Application
Skin will be assessed for adverse effects such as any device-related adverse events, including evidence of skin redness, rash and/or bruising or discomfort at the site of device application. Skin erythema was described as none, mild, moderate or severe as evaluated by the NICU nursing staff.
Time frame: Skin erythema was evaluated at the time of device removal after 1 hour of application in phase #1 and after 3 daily 8 hour periods of application in phase #2.
Population: Phase #2 data reports the number of participants experiencing erythema at any time after device removal after 3 daily 8 hour periods of device application.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Phase #1 | Number of Participants With Skin Erythema After Device Application | Skin Erythema after Device Application | Moderate Skin Erythema | 0 Participants |
| Phase #1 | Number of Participants With Skin Erythema After Device Application | Skin Erythema after Device Application | Mild Skin Erythema | 15 Participants |
| Phase #1 | Number of Participants With Skin Erythema After Device Application | Skin Erythema at Baseline | Mild Skin Erythema | 0 Participants |
| Phase #1 | Number of Participants With Skin Erythema After Device Application | Skin Erythema after Device Application | Severe Skin Erythema | 0 Participants |
| Phase #1 | Number of Participants With Skin Erythema After Device Application | Skin Erythema at Baseline | Moderate Skin Erythema | 0 Participants |
| Phase #1 | Number of Participants With Skin Erythema After Device Application | Skin Erythema after Device Application | No Skin Erythema | 10 Participants |
| Phase #1 | Number of Participants With Skin Erythema After Device Application | Skin Erythema at Baseline | Severe Skin Erythema | 0 Participants |
| Phase #1 | Number of Participants With Skin Erythema After Device Application | Skin Erythema after Device Application | Skin Breakdown | 0 Participants |
| Phase #1 | Number of Participants With Skin Erythema After Device Application | Skin Erythema at Baseline | Skin Breakdown | 0 Participants |
| Phase #1 | Number of Participants With Skin Erythema After Device Application | Skin Erythema at Baseline | No Skin Erythema | 25 Participants |
| Phase #2 | Number of Participants With Skin Erythema After Device Application | Skin Erythema at Baseline | Skin Breakdown | 0 Participants |
| Phase #2 | Number of Participants With Skin Erythema After Device Application | Skin Erythema after Device Application | No Skin Erythema | 10 Participants |
| Phase #2 | Number of Participants With Skin Erythema After Device Application | Skin Erythema after Device Application | Mild Skin Erythema | 14 Participants |
| Phase #2 | Number of Participants With Skin Erythema After Device Application | Skin Erythema after Device Application | Moderate Skin Erythema | 0 Participants |
| Phase #2 | Number of Participants With Skin Erythema After Device Application | Skin Erythema after Device Application | Severe Skin Erythema | 1 Participants |
| Phase #2 | Number of Participants With Skin Erythema After Device Application | Skin Erythema after Device Application | Skin Breakdown | 0 Participants |
| Phase #2 | Number of Participants With Skin Erythema After Device Application | Skin Erythema at Baseline | No Skin Erythema | 25 Participants |
| Phase #2 | Number of Participants With Skin Erythema After Device Application | Skin Erythema at Baseline | Mild Skin Erythema | 0 Participants |
| Phase #2 | Number of Participants With Skin Erythema After Device Application | Skin Erythema at Baseline | Moderate Skin Erythema | 0 Participants |
| Phase #2 | Number of Participants With Skin Erythema After Device Application | Skin Erythema at Baseline | Severe Skin Erythema | 0 Participants |
Secondary
Number of Participants With Specific Responses to the Ease of Use Questionnaire for NICU Staff.
A \>80% positive response to a multi-question Ease-of-Use Questionnaire completed by the participating NICU staff. Ease-of-Use Questionnaire constructed on a 5 point Likert Scale: 1 = Strongly Disagree, 2 = Disagree, 3 = Neutral, 4 = Agree, 5 = Strongly Agree that the device was easy-to-use. Phase #1 consists of 25 data points. Phase #2 consists of 25 data points. Evaluations were obtained after device removal in both phases.
Time frame: After 1 hour in phase #1 / After 3 x 8 hours in phase #2
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase #1 | Number of Participants With Specific Responses to the Ease of Use Questionnaire for NICU Staff. | Disagree | 0 Participants |
| Phase #1 | Number of Participants With Specific Responses to the Ease of Use Questionnaire for NICU Staff. | Agree | 4 Participants |
| Phase #1 | Number of Participants With Specific Responses to the Ease of Use Questionnaire for NICU Staff. | Neutral | 0 Participants |
| Phase #1 | Number of Participants With Specific Responses to the Ease of Use Questionnaire for NICU Staff. | Strongly Agree | 21 Participants |
| Phase #1 | Number of Participants With Specific Responses to the Ease of Use Questionnaire for NICU Staff. | Strongly Disagree | 0 Participants |
| Phase #2 | Number of Participants With Specific Responses to the Ease of Use Questionnaire for NICU Staff. | Strongly Agree | 14 Participants |
| Phase #2 | Number of Participants With Specific Responses to the Ease of Use Questionnaire for NICU Staff. | Strongly Disagree | 0 Participants |
| Phase #2 | Number of Participants With Specific Responses to the Ease of Use Questionnaire for NICU Staff. | Disagree | 0 Participants |
| Phase #2 | Number of Participants With Specific Responses to the Ease of Use Questionnaire for NICU Staff. | Neutral | 1 Participants |
| Phase #2 | Number of Participants With Specific Responses to the Ease of Use Questionnaire for NICU Staff. | Agree | 10 Participants |