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

NCT05091840 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2021-10-25

No results posted yet for this study

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.

Conditions

  • Respiratory Distress Syndrome of Prematurity

Interventions

OTHER

oximetry monitoring

monitoring oximetry in both groups using the INVOS™ system 5100C Oximeter

Sponsors & Collaborators

  • Hospital General Universitario Gregorio Marañon

    lead OTHER

Eligibility

Min Age
24 Weeks
Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-25
Primary Completion
2022-10-30
Completion
2023-08-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05091840 on ClinicalTrials.gov