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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05091840
Enrollment
40
Registered
2021-10-25
Start date
2021-10-25
Completion date
2023-08-30
Last updated
2021-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome of Prematurity

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.

Interventions

OTHERoximetry monitoring

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

Sponsors

Hospital General Universitario Gregorio Marañon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
24 Weeks to 32 Weeks
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* major congenital malformations * chromosomopathies

Design outcomes

Primary

MeasureTime frame
to evaluate the impact on cerebral and renal oximetry in preterm infants less than 32 weeks who are administered surfactantoximetry monitoring first 24 hours after birth

Contacts

Primary ContactManuel Sanchez Luna
msluna@salud.madrid.org34 91 529 00 18

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026