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Clinical Trials/NCT05091840
NCT05091840
Unknown
Not Applicable

Cerebral and Renal Oximetry Study in Preterm Patients Who Require Surfactant Administration

Hospital General Universitario Gregorio Marañon0 sites40 target enrollmentOctober 25, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Distress Syndrome of Prematurity
Sponsor
Hospital General Universitario Gregorio Marañon
Enrollment
40
Primary Endpoint
to evaluate the impact on cerebral and renal oximetry in preterm infants less than 32 weeks who are administered surfactant
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 25, 2021
End Date
August 30, 2023
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Hospital General Universitario Gregorio Marañon
Responsible Party
Principal Investigator
Principal Investigator

Manuel Sanchez Luna

Chief Neonatology Service

Hospital General Universitario Gregorio Marañon

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • major congenital malformations
  • chromosomopathies

Outcomes

Primary Outcomes

to evaluate the impact on cerebral and renal oximetry in preterm infants less than 32 weeks who are administered surfactant

Time Frame: oximetry monitoring first 24 hours after birth

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