Clinical trial NCT05091840: Cerebral and Renal Oximetry Study in Preterm Patients Who Require Surfactant Administration
Official title: Cerebral and Renal Oximetry Study in Preterm Patients Who Require Surfactant Administration
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Distress Syndrome of Prematurity
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 40
Sex: ALL
Minimum age (years): 24
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients less than 32 weeks gestational age born in our center (Hospital General Universitario Gregorio Marañon) who require surfactant administration will be included

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* preterm infants less than 32 weeks gestational age requiring surfactant administration

Exclusion Criteria:

* major congenital malformations
* chromosomopathies

Primary outcomes:
measure: to evaluate the impact on cerebral and renal oximetry in preterm infants less than 32 weeks who are administered surfactant
timeFrame: oximetry monitoring first 24 hours after birth
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.