Trial Outcomes & Findings for A Pilot Study to Evaluate Patient Tolerance and Nursing Ease-of-Use of a Novel Hearing Protection Device (NCT NCT02744066)
NCT ID: NCT02744066
Last Updated: 2018-11-29
Results Overview
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.
COMPLETED
NA
55 participants
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.
2018-11-29
Participant Flow
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.
Participant milestones
| Measure |
Phase #1
Infants recruited in phase #1 had the device placed for 1 hour, with recordings of vital signs before and after devise placement.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
30
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
5
|
Reasons for withdrawal
| Measure |
Phase #1
Infants recruited in phase #1 had the device placed for 1 hour, with recordings of vital signs before and after devise placement.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by parent
|
0
|
1
|
|
Overall Study
Discharged from NICU prior to completion
|
0
|
4
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Phase #1
n=25 Participants
Infants recruited in phase #1 had the device placed for 1 hour, with recordings of vital signs before and after devise placement.
|
Phase #2
n=25 Participants
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.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
25 Participants
n=25 Participants
|
25 Participants
n=25 Participants
|
50 Participants
n=50 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=25 Participants
|
8 Participants
n=25 Participants
|
18 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=25 Participants
|
17 Participants
n=25 Participants
|
32 Participants
n=50 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Gestational Age at Birth
|
36.6 Weeks
STANDARD_DEVIATION 3.29 • n=25 Participants
|
34.8 Weeks
STANDARD_DEVIATION 3.87 • n=25 Participants
|
35.7 Weeks
STANDARD_DEVIATION 3.7 • n=50 Participants
|
|
Birth Weight
|
2.6 kilograms
STANDARD_DEVIATION 0.84 • n=25 Participants
|
2.3 kilograms
STANDARD_DEVIATION 0.94 • n=25 Participants
|
2.5 kilograms
STANDARD_DEVIATION 0.9 • n=50 Participants
|
|
Head Circumference
|
32.3 centimeters
STANDARD_DEVIATION 3.03 • n=25 Participants
|
31.4 centimeters
STANDARD_DEVIATION 3.66 • n=25 Participants
|
31.8 centimeters
STANDARD_DEVIATION 3.4 • n=50 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Phase #1
n=25 Participants
Infants recruited in phase #1 had the device placed for 1 hour, with recordings of vital signs before and after devise placement.
|
Phase #2
n=25 Participants
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.
|
|---|---|---|
|
Number of Participants With Skin Erythema After Device Application
Skin Erythema after Device Application · No Skin Erythema
|
10 Participants
|
10 Participants
|
|
Number of Participants With Skin Erythema After Device Application
Skin Erythema after Device Application · Mild Skin Erythema
|
15 Participants
|
14 Participants
|
|
Number of Participants With Skin Erythema After Device Application
Skin Erythema after Device Application · Moderate Skin Erythema
|
0 Participants
|
0 Participants
|
|
Number of Participants With Skin Erythema After Device Application
Skin Erythema after Device Application · Severe Skin Erythema
|
0 Participants
|
1 Participants
|
|
Number of Participants With Skin Erythema After Device Application
Skin Erythema after Device Application · Skin Breakdown
|
0 Participants
|
0 Participants
|
|
Number of Participants With Skin Erythema After Device Application
Skin Erythema at Baseline · No Skin Erythema
|
25 Participants
|
25 Participants
|
|
Number of Participants With Skin Erythema After Device Application
Skin Erythema at Baseline · Mild Skin Erythema
|
0 Participants
|
0 Participants
|
|
Number of Participants With Skin Erythema After Device Application
Skin Erythema at Baseline · Moderate Skin Erythema
|
0 Participants
|
0 Participants
|
|
Number of Participants With Skin Erythema After Device Application
Skin Erythema at Baseline · Severe Skin Erythema
|
0 Participants
|
0 Participants
|
|
Number of Participants With Skin Erythema After Device Application
Skin Erythema at Baseline · Skin Breakdown
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: After 1 hour in phase #1 / After 3 x 8 hours in phase #2A \>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.
Outcome measures
| Measure |
Phase #1
n=25 Participants
Infants recruited in phase #1 had the device placed for 1 hour, with recordings of vital signs before and after devise placement.
|
Phase #2
n=25 Participants
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.
|
|---|---|---|
|
Number of Participants With Specific Responses to the Ease of Use Questionnaire for NICU Staff.
Strongly Disagree
|
0 Participants
|
0 Participants
|
|
Number of Participants With Specific Responses to the Ease of Use Questionnaire for NICU Staff.
Disagree
|
0 Participants
|
0 Participants
|
|
Number of Participants With Specific Responses to the Ease of Use Questionnaire for NICU Staff.
Neutral
|
0 Participants
|
1 Participants
|
|
Number of Participants With Specific Responses to the Ease of Use Questionnaire for NICU Staff.
Agree
|
4 Participants
|
10 Participants
|
|
Number of Participants With Specific Responses to the Ease of Use Questionnaire for NICU Staff.
Strongly Agree
|
21 Participants
|
14 Participants
|
Adverse Events
Phase #1
Phase #2
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phase #1
n=25 participants at risk
Infants recruited in phase #1 had the device placed for 1 hour, with recordings of vital signs before and after devise placement.
|
Phase #2
n=25 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Severe Erythema
|
0.00%
0/25 • Adverse event data were collected immediately after device removal for both arms of the study.
Systematic Assessment of the skin condition of study subjects by participating NICU nurses was conducted per protocol for 25 infants in phase #1 and 25 infants in phase #2.
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected immediately after device removal for both arms of the study.
Systematic Assessment of the skin condition of study subjects by participating NICU nurses was conducted per protocol for 25 infants in phase #1 and 25 infants in phase #2.
|
Additional Information
Dr. Michael J. Balsan
Magee Womens, UPMC Hamot Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place