An interventional study of Nasal CPAP interface: OptiPAP Junior and Nasal CPAP interface: FlexiTrunk in Bronchopulmonary Dysplasia (BPD), Preterm Birth Complication and Pulmonary, sponsored by Sharp HealthCare. Not yet recruiting at 1 site in United States. Open to participants aged Up to 30 Weeks. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Sharp HealthCare · Not applicable, Interventional, and Supportive care
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.
The information gathered in this study is relevant to all NICU families of children who need respiratory support as the investigators will assess parent perceptions of different devices, namely the OptiPAP Junior, as well as aspects of respiratory support to share with the broader NICU community and change how NICU providers talk about these devices and lung outcomes with parents.
362 studies on the registry are indexed under Bronchopulmonary Dysplasia; 85 are open to participants now.
This study's planned enrollment of 60 is close to the median of 66 across 244 interventional studies indexed under Bronchopulmonary Dysplasia.
Browse Bronchopulmonary Dysplasia studies →Sharp HealthCare is the lead sponsor of 40 studies on the registry; 4 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
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.
Device: Nasal CPAP interface: OptiPAP Junior
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.
Device: Nasal CPAP interface: FlexiTrunk
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
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.
Parent perception of different respiratory devices
To assess parent perception of different respiratory devices, namely the OptiPAP Junior, in comparison to other modalities through semi-structured parent interviews.
Time frame: From baseline to study completion, an average of 3 months.
Parent perception and recommendations on inpatient pulmonary support and outcome measurements
To detail family member perception of lung disease and respiratory support, parent recommendations of how to improve NICU bonding in setting of respiratory needs, and parent recommendations on inpatient pulmonary outcome measurements through semi-structured parent interviews.
Time frame: From baseline to study completion, an average of 3 months.
Plan to share: Yes — Individual participant data, particularly data that underlie the results reported in this article after deidentification will be available with other researchers, including data dictionaries for meta-analysis.
Start is estimated for Oct 2026; primary completion for Dec 2027, 14 months later.
Of 71 non-industry interventional studies with no phase under Bronchopulmonary Dysplasia, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 56. This study's planned 14 months is below that.
Counting every sponsor, half of 73 studies reached it within 37 months; a quarter within 19 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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