Parent Perceptions of OptiPAP Junior

Part of paid clinical trials in San Diego, California.

Sponsor
Sharp HealthCare
Study ID
NCT07837700
Status
Not Yet Recruiting

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Conditions

  • Bronchopulmonary Dysplasia (BPD)
  • CPAP
  • Preterm Birth Complication
  • Pulmonary

Eligibility Criteria

Sex
ALL
Age
N/A - 30 Weeks
Healthy Volunteers
Not accepted

Interventions

  • Nasal CPAP interface: OptiPAP Junior — DEVICE
    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 — DEVICE
    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.

Study Details

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 Dates

First listed
Sep 23, 2026
Start date
Oct 31, 2026
Status verified
Sep 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: OptiPAP Junior
    The OptiPAP Junior device (Fisher \& Paykel) is an FDA cleared device interface for the provision of pressure-based respiratory support to be used in accordance with its approved labeling.
  • Active Comparator: Flexitrunk
    The Flexitrunk (Fisher \& Paykel) is a predominant interface used in neonatal care units. Flexitrunk is an FDA cleared device interface for the provision of pressure-based respiratory support to be used in accordance with its approved labeling.

Primary Outcome Measure

Parent perception of different respiratory devices [ Time Frame: From baseline to study completion, an average of 3 months. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sharp Mary Birch Hospital for Women & NewbornsSan DiegoCalifornia92123
Rebecca Dorner, MD, MHS
[email protected]
858-939-4391
Rebecca Dorner, MD, MHS (PRINCIPAL_INVESTIGATOR)

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By research site
Sharp Mary Birch Hospital for Women & Newborns· San Diego, CA

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