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Parent Perceptions of OptiPAP Junior
Sponsor: Sharp HealthCare
Summary
To evaluate how different forms of respiratory support affect parent interaction, how parents feel about different methods of support, and how their child's current respiratory support level is perceived in the setting of long-term outcomes.
Key Details
Gender
All
Age Range
Any - 30 Weeks
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-10
Completion Date
2027-12
Last Updated
2026-09-23
Healthy Volunteers
No
Interventions
Nasal CPAP interface: OptiPAP Junior
FDA 510(k)-cleared non-invasive nasal interface used to deliver continuous positive airway pressure. Infants receive CPAP via the OptiPAP Junior interface for 5 consecutive days, either as the first or second interface depending on randomized sequence. CPAP level and duration are managed by the clinical team per standard NICU practice; the device is used in accordance with its cleared labeling
Nasal CPAP interface: FlexiTrunk
FDA-cleared Class I, 510(k)-exempt nasal interface that is the standard CPAP interface in many neonatal care units. Infants receive CPAP via the FlexiTrunk interface for 5 consecutive days, either as the first or second interface depending on randomized sequence. CPAP level and duration are managed by the clinical team per standard NICU practice.
Locations (1)
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, United States