NCT05091840

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

Status unknown Last updated 25 October 2021

What this trial tests

trial testing oximetry monitoring in Respiratory Distress Syndrome of Prematurity in 40 participants. Status unknown.

Timeline

25 October 2021

Primary endpoint
30 October 2022

30 August 2023

Quick facts

Lead sponsor	Hospital General Universitario Gregorio Marañon
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	40
Start date	25 October 2021
Primary completion	30 October 2022
Estimated completion	30 August 2023

Drugs / interventions tested

• oximetry monitoring

Conditions studied

• Respiratory Distress Syndrome of Prematurity — all drugs for Respiratory Distress Syndrome of Prematurity →

Sponsor

Hospital General Universitario Gregorio Marañon

Who can join

Adults 24 Weeks to 32 Weeks, any sex, with Respiratory Distress Syndrome of Prematurity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.