Parent Perceptions of OptiPAP Junior

ConditionsBronchopulmonary Dysplasia (BPD)Preterm Birth Complication Pulmonary CPAP

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

AgeUp to 30

SponsorSharp HealthCare

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Infants born less than 31 weeks who have been stable for 72 hours on continuous positive pressure level (CPAP) of support via a standard interface.

Parents (females or males) must be greater than 18 years of age at the time of the interview after their infant has experienced both respiratory modalities.

Disqualifiers

Infants will be excluded if they have suspected or confirmed abnormalities/trauma to the skull or airway involving any abnormal connection that may allow pressure to be transmitted to unintended anatomical structures or tissues.

Trial design

Design model

Crossover

Treatments tested in this trial

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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: OptiPAP JuniorExperimental treatment 1 intervention

Group B: FlexitrunkActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and contacts

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Sharp HealthCare

Lead sponsor

Fisher & Paykel

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: