Parent Perceptions of OptiPAP Junior
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Rebecca Dorner, MD, MHS
- Número de teléfono: 858-939-4391
- Correo electrónico: Rebecca.Dorner@sharp.com
Ubicaciones de estudio
-
-
California
-
San Diego, California, Estados Unidos, 92123
- Sharp Mary Birch Hospital for Women & Newborns
-
Contacto:
- Rebecca Dorner, MD, MHS
- Número de teléfono: 858-939-4391
- Correo electrónico: Rebecca.Dorner@sharp.com
-
Investigador principal:
- Rebecca Dorner, MD, MHS
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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. |
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 |
|
Comparador activo: 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. |
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Parent perception of different respiratory devices
Periodo de tiempo: 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. |
From baseline to study completion, an average of 3 months.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Parent perception and recommendations on inpatient pulmonary support and outcome measurements
Periodo de tiempo: 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. |
From baseline to study completion, an average of 3 months.
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Parent Perceptions of OptiPAP
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .