- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: Manuel Sanchez Luna
- Telefonnummer: 34 91 529 00 18
- E-post: msluna@salud.madrid.org
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- preterm infants less than 32 weeks gestational age requiring surfactant administration
Exclusion Criteria:
- major congenital malformations
- chromosomopathies
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
to evaluate the impact on cerebral and renal oximetry in preterm infants less than 32 weeks who are administered surfactant
Tidsramme: oximetry monitoring first 24 hours after birth
|
oximetry monitoring first 24 hours after birth
|
Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
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
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