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NOT YET RECRUITING
NCT07837700
NA

Parent Perceptions of OptiPAP Junior

Sponsor: Sharp HealthCare

View on ClinicalTrials.gov

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

DEVICE

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

DEVICE

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