- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05091840
Cerebral and Renal Oximetry Study in Preterm Patients Who Require Surfactant Administration
Respiratory distress syndrome of prematurity (RDSP) is an acute respiratory condition that occurs in preterm infants due to pulmonary surfactant deficiency.
Exogenous surfactant administration is a crucial therapeutic measure in the management of RDSP, being the 'less invasive surfactant administration technique' (LISA) the gold standard, according to the latest reviews.
Oximetry based on near-infrared spectroscopy is a non-invasive monitoring modality that provides continuous information on the degree of regional hemoglobin saturation present in the underlying tissue, mainly in the venous compartment. It is thus, a reflection of the balance between oxygen supply and demand of oxygen to the tissues.
We intend to perform a prospective analysis of newborns under 32 weeks of gestational age who require surfactant administration, as we wish to study cerebral and renal perfusion by oximetry in the group of patients who receive surfactant by LISA and in the group of patients who receive surfactant via endotracheal tube (patients intubated at birth for stabilization), since there are few data published in the literature.
Our main hypothesis is that the administration of surfactant by LISA technique does not negatively influence cerebral and renal oximetry.
Our secondary hypothesis is that patients requiring intubation at birth will present greater hemodynamic and respiratory instability in the first 72 hours of life, with a greater decrease in cerebral and renal oximetry with the administration of surfactant, compared to the group that does not require intubation at birth.
연구 개요
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Manuel Sanchez Luna
- 전화번호: 34 91 529 00 18
- 이메일: msluna@salud.madrid.org
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- preterm infants less than 32 weeks gestational age requiring surfactant administration
Exclusion Criteria:
- major congenital malformations
- chromosomopathies
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
patients requiring intubation at birth and subsequent surfactant administration
|
monitoring oximetry in both groups using the INVOS™ system 5100C Oximeter
|
patients who receive surfactant by LISA
|
monitoring oximetry in both groups using the INVOS™ system 5100C Oximeter
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
to evaluate the impact on cerebral and renal oximetry in preterm infants less than 32 weeks who are administered surfactant
기간: oximetry monitoring first 24 hours after birth
|
oximetry monitoring first 24 hours after birth
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Te Pas A, Plavka R, Roehr CC, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GHA, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2019 Update. Neonatology. 2019;115(4):432-450. doi: 10.1159/000499361. Epub 2019 Apr 11.
- Sood BG, McLaughlin K, Cortez J. Near-infrared spectroscopy: applications in neonates. Semin Fetal Neonatal Med. 2015 Jun;20(3):164-72. doi: 10.1016/j.siny.2015.03.008. Epub 2015 Apr 29.
- Bellos I, Fitrou G, Panza R, Pandita A. Comparative efficacy of methods for surfactant administration: a network meta-analysis. Arch Dis Child Fetal Neonatal Ed. 2021 Sep;106(5):474-487. doi: 10.1136/archdischild-2020-319763. Epub 2021 Jan 15.
- Abdel-Latif ME, Davis PG, Wheeler KI, De Paoli AG, Dargaville PA. Surfactant therapy via thin catheter in preterm infants with or at risk of respiratory distress syndrome. Cochrane Database Syst Rev. 2021 May 10;5(5):CD011672. doi: 10.1002/14651858.CD011672.pub2.
- Scott JP, Hoffman GM. Near-infrared spectroscopy: exposing the dark (venous) side of the circulation. Paediatr Anaesth. 2014 Jan;24(1):74-88. doi: 10.1111/pan.12301. Epub 2013 Nov 23.
- Hanke K, Rausch TK, Paul P, Hellwig I, Kramer C, Stichtenoth G, Herz A, Wieg C, Konig IR, Gopel W, Herting E, Hartel C. The effect of less invasive surfactant administration on cerebral oxygenation in preterm infants. Acta Paediatr. 2020 Feb;109(2):291-299. doi: 10.1111/apa.14939. Epub 2019 Sep 5.
- Bertini G, Coviello C, Gozzini E, Bianconi T, Bresci C, Leonardi V, Dani C. Change of Cerebral Oxygenation during Surfactant Treatment in Preterm Infants: "LISA" versus "InSurE" Procedures. Neuropediatrics. 2017 Apr;48(2):98-103. doi: 10.1055/s-0037-1598647. Epub 2017 Feb 28.
- Rey-Santano C, Mielgo VE, Gomez-Solaetxe MA, Salomone F, Gastiasoro E, Loureiro B. Cerebral oxygenation associated with INSURE versus LISA procedures in surfactant-deficient newborn piglet RDS model. Pediatr Pulmonol. 2019 May;54(5):644-654. doi: 10.1002/ppul.24277. Epub 2019 Feb 18.
- Pellicer A, Greisen G, Benders M, Claris O, Dempsey E, Fumagalli M, Gluud C, Hagmann C, Hellstrom-Westas L, Hyttel-Sorensen S, Lemmers P, Naulaers G, Pichler G, Roll C, van Bel F, van Oeveren W, Skoog M, Wolf M, Austin T. The SafeBoosC phase II randomised clinical trial: a treatment guideline for targeted near-infrared-derived cerebral tissue oxygenation versus standard treatment in extremely preterm infants. Neonatology. 2013;104(3):171-8. doi: 10.1159/000351346. Epub 2013 Aug 1.
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Neuro.Neo.4
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. .
oximetry monitoring에 대한 임상 시험
-
Seoul National University HospitalSeoul National University모집하지 않고 적극적으로
-
Singapore General HospitalKK Women's and Children's Hospital; SingHealth Polyclinics완전한
-
Kaohsiung Medical University Chung-Ho Memorial...모병
-
University Hospital, MontpellierFrench Society of Emergency Medicine알려지지 않은
-
Royal Brompton & Harefield NHS Foundation TrustUniversity of Oxford; National Institute for Health Research, United Kingdom완전한