N/A
N=55
A Pilot Study to Evaluate Patient Tolerance and Nursing Ease-of-Use of a Novel Hearing Protection Device
Hearing Impairment
Bottom Line
View on ClinicalTrials.gov: NCT02744066 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Number of Participants With Skin Erythema After Device Application — 10; 10; 15; 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- NEATCAP (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Michael Balsan, MD
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Skin Erythema After Device Application |
10; 10; 15; 14; 0; 0 | — |
| SECONDARY Number of Participants With Specific Responses to the Ease of Use Questionnaire for NICU Staff. |
0; 0; 0; 0; 0; 1 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02744066). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.