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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Rebecca Dorner, MD, MHS
- 전화번호: 858-939-4391
- 이메일: Rebecca.Dorner@sharp.com
연구 장소
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California
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San Diego, California, 미국, 92123
- Sharp Mary Birch Hospital for Women & Newborns
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연락하다:
- Rebecca Dorner, MD, MHS
- 전화번호: 858-939-4391
- 이메일: Rebecca.Dorner@sharp.com
-
수석 연구원:
- Rebecca Dorner, MD, MHS
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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 |
|
활성 비교기: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Parent perception of different respiratory devices
기간: 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.
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Parent perception and recommendations on inpatient pulmonary support and outcome measurements
기간: 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.
|
공동 작업자 및 조사자
협력자
협력자
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- Parent Perceptions of OptiPAP
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .