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

October 13, 2021 updated by: Manuel Sanchez Luna, Hospital General Universitario Gregorio Marañon

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • major congenital malformations
  • chromosomopathies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients requiring intubation at birth and subsequent surfactant administration
Other: oximetry monitoring
monitoring oximetry in both groups using the INVOS™ system 5100C Oximeter
patients who receive surfactant by LISA
Other: oximetry monitoring
monitoring oximetry in both groups using the INVOS™ system 5100C Oximeter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
oximetry monitoring first 24 hours after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Universitario Gregorio Marañon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 25, 2021

Primary Completion (Anticipated)

October 30, 2022

Study Completion (Anticipated)

August 30, 2023

Study Registration Dates

First Submitted

October 13, 2021

First Submitted That Met QC Criteria

October 13, 2021

First Posted (Actual)

October 25, 2021

Study Record Updates

Last Update Posted (Actual)

October 25, 2021

Last Update Submitted That Met QC Criteria

October 13, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Neuro.Neo.4

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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