Bronchopulmonary Dysplasia (BPD)NCT07837700
Parent Perceptions of OptiPAP Junior
A study testing Nasal CPAP interface: OptiPAP Junior and Nasal CPAP interface: FlexiTrunk in people with Bronchopulmonary Dysplasia (BPD) and Preterm Birth Complication, run by Sharp HealthCare at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 30 weeks
- Conditions the study is for
- Bronchopulmonary Dysplasia (BPD), Preterm Birth Complication, Pulmonary
- What is being tested?
- Nasal CPAP interface: OptiPAP Junior and Nasal CPAP interface: FlexiTrunk
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 30 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, 92123
Rebecca Dorner, MD, MHS, 858-939-4391, Rebecca.Dorner@sharp.com
Rebecca Dorner, MD, MHS
About this study
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.
Read the detailed description
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.
- Being tested
- Nasal CPAP interface: OptiPAP Junior, Nasal CPAP interface: FlexiTrunk
- Keywords
- parent perception, NICU, respiratory support
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal CPAP interface: OptiPAP JuniorDevice
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: FlexiTrunkDevice
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 group | Role | What they receive |
|---|---|---|
| OptiPAP Junior | Experimental | 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. Receives: Device: Nasal CPAP interface: OptiPAP Junior |
| Flexitrunk | Active comparator | 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. Receives: Device: Nasal CPAP interface: FlexiTrunk |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to study completion, an average of 3 months.
Secondary outcomes (1)
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.
Measured: From baseline to study completion, an average of 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Bronchopulmonary Dysplasia (BPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sharp HealthCare
- Sponsor type
- University, hospital or other
- Collaborators
- Fisher & Paykel
- Responsible party
- Principal investigator, Rebecca Dorner, MD, MHS, Sharp HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837700
- Sponsor's protocol ID
- Parent Perceptions of OptiPAP
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Ando H, Cousins R, Young C. Achieving Saturation in Thematic Analysis: Development and Refinement of a Codebook. Comprehensive Psychology. 2014;3:03.CP.3.4.
Guest G, Bunce A, Johnson L. How Many Interviews Are Enough? Field Methods - FIELD METHOD. 2006;18:59-82.
Dorner RA, Boss RD, Vazifedan T, Johnson E, Garzon A, Lemmon ME. Life on the Frontlines: Caregiver Experience of Pediatric Cerebrospinal Shunt Malfunction. Pediatr Neurol. 2023 Oct;147:124-129. doi: 10.1016/j.pediatrneurol.2023.07.021. Epub 2023 Aug 2.
PubMed 37611406Dorner RA, Boss RD, Burton VJ, Raja K, Lemmon ME. Parent preferences for neurodevelopmental screening in the neonatal intensive care unit. Dev Med Child Neurol. 2020 Apr;62(4):500-505. doi: 10.1111/dmcn.14457. Epub 2020 Jan 7.
PubMed 31909496Dorner RA, Boss RD, Burton VJ, Raja K, Robinson S, Lemmon ME. Isolated and On Guard: Preparing Neonatal Intensive Care Unit Families for Life with Hydrocephalus. Am J Perinatol. 2022 Sep;39(12):1341-1347. doi: 10.1055/s-0040-1722344. Epub 2021 Jan 17.
PubMed 33454943Thivierge E, Luu TM, Bourque CJ, Barrington KJ, Pearce R, Jaworski M, Janvier A. Pulmonary important outcomes after extremely preterm birth: Parental perspectives. Acta Paediatr. 2023 May;112(5):970-976. doi: 10.1111/apa.16723. Epub 2023 Mar 3.
PubMed 36815277Callahan KP, Kielt MJ, Feudtner C, Barkman D, Bamat N, Fierro J, Fiest E, DeMauro SB. Ranking Future Outcomes Most Important to Parents of Children with Bronchopulmonary Dysplasia. J Pediatr. 2023 Aug;259:113455. doi: 10.1016/j.jpeds.2023.113455. Epub 2023 May 10.
PubMed 37172804Klingenberg C, Pettersen M, Hansen EA, Gustavsen LJ, Dahl IA, Leknessund A, Kaaresen PI, Nordhov M. Patient comfort during treatment with heated humidified high flow nasal cannulae versus nasal continuous positive airway pressure: a randomised cross-over trial. Arch Dis Child Fetal Neonatal Ed. 2014 Mar;99(2):F134-7. doi: 10.1136/archdischild-2013-304525. Epub 2013 Nov 13.
PubMed 24225220Manley BJ, Owen L, Doyle LW, Davis PG. High-flow nasal cannulae and nasal continuous positive airway pressure use in non-tertiary special care nurseries in Australia and New Zealand. J Paediatr Child Health. 2012 Jan;48(1):16-21. doi: 10.1111/j.1440-1754.2011.02186.x. Epub 2011 Oct 12.
PubMed 21988616Abman SH, Bancalari E, Jobe A. The Evolution of Bronchopulmonary Dysplasia after 50 Years. Am J Respir Crit Care Med. 2017 Feb 15;195(4):421-424. doi: 10.1164/rccm.201611-2386ED. No abstract available.
PubMed 28199157
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent Perceptions of OptiPAP Junior
- ClinicalTrials.gov ID
- NCT07837700
- Acronym / sponsor ID
- Parent Perceptions of OptiPAP
- Keywords
- parent perception, NICU, respiratory support
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sharp HealthCareUniversity, hospital or other
- Collaborators
- Fisher & Paykel
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OptiPAP Junior | Experimental | Device: Nasal CPAP interface: OptiPAP JuniorThe 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. |
| Flexitrunk | Active comparator | Device: Nasal CPAP interface: FlexiTrunkThe 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. |
Who may qualify
- Ages
- Up to 30 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal CPAP interface: OptiPAP JuniorFDA 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 | OptiPAP Junior |
| Nasal CPAP interface: FlexiTrunkFDA-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. | Device | Flexitrunk |
Primary outcome
Parent perception of different respiratory devices
Time frame: From baseline to study completion, an average of 3 months.
To assess parent perception of different respiratory devices, namely the OptiPAP Junior, in comparison to other modalities through semi-structured parent interviews.
1 secondary outcome
Parent perception and recommendations on inpatient pulmonary support and outcome measurements
Time frame: From baseline to study completion, an average of 3 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- BackgroundAndo H, Cousins R, Young C. Achieving Saturation in Thematic Analysis: Development and Refinement of a Codebook. Comprehensive Psychology. 2014;3:03.CP.3.4.
- BackgroundGuest G, Bunce A, Johnson L. How Many Interviews Are Enough? Field Methods - FIELD METHOD. 2006;18:59-82.
- Background: PubMed 37611406Dorner RA, Boss RD, Vazifedan T, Johnson E, Garzon A, Lemmon ME. Life on the Frontlines: Caregiver Experience of Pediatric Cerebrospinal Shunt Malfunction. Pediatr Neurol. 2023 Oct;147:124-129. doi: 10.1016/j.pediatrneurol.2023.07.021. Epub 2023 Aug 2.
- Background: PubMed 31909496Dorner RA, Boss RD, Burton VJ, Raja K, Lemmon ME. Parent preferences for neurodevelopmental screening in the neonatal intensive care unit. Dev Med Child Neurol. 2020 Apr;62(4):500-505. doi: 10.1111/dmcn.14457. Epub 2020 Jan 7.
- Background: PubMed 33454943Dorner RA, Boss RD, Burton VJ, Raja K, Robinson S, Lemmon ME. Isolated and On Guard: Preparing Neonatal Intensive Care Unit Families for Life with Hydrocephalus. Am J Perinatol. 2022 Sep;39(12):1341-1347. doi: 10.1055/s-0040-1722344. Epub 2021 Jan 17.
- Background: PubMed 36815277Thivierge E, Luu TM, Bourque CJ, Barrington KJ, Pearce R, Jaworski M, Janvier A. Pulmonary important outcomes after extremely preterm birth: Parental perspectives. Acta Paediatr. 2023 May;112(5):970-976. doi: 10.1111/apa.16723. Epub 2023 Mar 3.
- Background: PubMed 37172804Callahan KP, Kielt MJ, Feudtner C, Barkman D, Bamat N, Fierro J, Fiest E, DeMauro SB. Ranking Future Outcomes Most Important to Parents of Children with Bronchopulmonary Dysplasia. J Pediatr. 2023 Aug;259:113455. doi: 10.1016/j.jpeds.2023.113455. Epub 2023 May 10.
- Background: PubMed 24225220Klingenberg C, Pettersen M, Hansen EA, Gustavsen LJ, Dahl IA, Leknessund A, Kaaresen PI, Nordhov M. Patient comfort during treatment with heated humidified high flow nasal cannulae versus nasal continuous positive airway pressure: a randomised cross-over trial. Arch Dis Child Fetal Neonatal Ed. 2014 Mar;99(2):F134-7. doi: 10.1136/archdischild-2013-304525. Epub 2013 Nov 13.
- Background: PubMed 21988616Manley BJ, Owen L, Doyle LW, Davis PG. High-flow nasal cannulae and nasal continuous positive airway pressure use in non-tertiary special care nurseries in Australia and New Zealand. J Paediatr Child Health. 2012 Jan;48(1):16-21. doi: 10.1111/j.1440-1754.2011.02186.x. Epub 2011 Oct 12.
- Background: PubMed 28199157Abman SH, Bancalari E, Jobe A. The Evolution of Bronchopulmonary Dysplasia after 50 Years. Am J Respir Crit Care Med. 2017 Feb 15;195(4):421-424. doi: 10.1164/rccm.201611-2386ED. No abstract available.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal CPAP interface: OptiPAP Junior and Nasal CPAP interface: FlexiTrunk in people with Bronchopulmonary Dysplasia (BPD) and Preterm Birth Complication, run by Sharp HealthCare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Dorner, MD, MHS (858-939-4391, Rebecca.Dorner@sharp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent perception of different respiratory devices (time frame: From baseline to study completion, an average of 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07837700, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.