| Registry | NCT07837700 |
|---|
| Status | Not yet recruiting |
|---|
| Phase | Not applicable |
|---|
| Study type | Interventional; randomized, crossover, masking: none, supportive care |
|---|
| Enrollment | 60 (Estimated) |
|---|
| Sponsor | Sharp HealthCare (Other); collaborators: Fisher & Paykel |
|---|
| Conditions | Bronchopulmonary Dysplasia (BPD), Preterm Birth Complication, Pulmonary, CPAP |
|---|
| Interventions | Nasal CPAP interface: OptiPAP Junior, Nasal CPAP interface: FlexiTrunk (Device) |
|---|
| Dates | start 2026-10-01 (estimated), primary completion 2027-12-01 (estimated), completion 2027-12-01 (estimated), first posted 2026-09-23, last updated 2026-09-23 |
|---|
| Locations | 1 site in United States |
|---|
Related Papers Related Patents Related Grants Related Experts
All trials for Bronchopulmonary Dysplasia (BPD) All trials for Preterm Birth Complication All trials of Nasal CPAP interface: OptiPAP Junior All trials of Nasal CPAP interface: FlexiTrunk
-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.
Expand all sections · Collapse all
+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| OptiPAP Junior | Experimental | Device: Nasal CPAP interface: 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. |
| Flexitrunk | Active comparator | Device: Nasal CPAP interface: 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. |
- 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.
+Outcome measures
Primary outcomes
- Parent perception of different respiratory devices [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.
Secondary outcomes
- Parent perception and recommendations on inpatient pulmonary support and outcome measurements [From baseline to study completion, an average of 3 months.]: 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.
+Eligibility
Sex: All, ages: any to 30 Weeks
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
+Locations (1)
| Facility | City | Country | Status |
|---|
| Sharp Mary Birch Hospital for Women & Newborns | San Diego, California | United States | |
+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. PMID 37611406
- Dorner 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. PMID 31909496
- Dorner 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. PMID 33454943
- Thivierge 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. PMID 36815277
- Callahan 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. PMID 37172804
- Klingenberg 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. PMID 24225220
- Manley 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. PMID 21988616
- Abman 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. PMID 28199157