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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Rebecca Dorner, MD, MHS
- Telefonnummer: 858-939-4391
- E-post: Rebecca.Dorner@sharp.com
Studiesteder
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California
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San Diego, California, Forente stater, 92123
- Sharp Mary Birch Hospital for Women & Newborns
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Ta kontakt med:
- Rebecca Dorner, MD, MHS
- Telefonnummer: 858-939-4391
- E-post: Rebecca.Dorner@sharp.com
-
Hovedetterforsker:
- Rebecca Dorner, MD, MHS
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 |
|
Aktiv komparator: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Parent perception of different respiratory devices
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Parent perception and recommendations on inpatient pulmonary support and outcome measurements
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Parent Perceptions of OptiPAP
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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