Parent Perceptions of OptiPAP Junior

NCT07837700 | Not Yet Recruiting

• 1 other identifier: Parent Perceptions of OptiPAP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

parent perception; NICU; respiratory support

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to study completion, an average of 3 months.

Secondary Outcomes (1)

• Parent perception and recommendations on inpatient pulmonary support and outcome measurements

  From baseline to study completion, an average of 3 months.

Study Arms (2)

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.

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.

Device: Nasal CPAP interface: FlexiTrunk

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

OptiPAP Junior

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.

Flexitrunk

Eligibility Criteria

• Age: Up to 30 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sharp HealthCare: lead
• Fisher & Paykel: collaborator

Study Sites (1)

Sharp Mary Birch Hospital for Women & Newborns

San Diego, California, 92123, United States

Location

Related Publications (10)

• 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.

  BACKGROUND

• Guest G, Bunce A, Johnson L. How Many Interviews Are Enough? Field Methods - FIELD METHOD. 2006;18:59-82.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Rebecca Dorner, MD, MHS

CONTACT

858-939-4391; Rebecca.Dorner@sharp.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 23, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)