Evaluation of the Brain and Renal Regional Oxygenation Using NIRS in Preterm Infants

January 3, 2023 updated by: Vilnius University

Evaluation of the Brain and Renal Regional Oxygenation Using Near Infrared Spectroscopy (NIRS) Method in Very Low Birth Weight (<1500 g) Infants

This study evaluates the brain and renal oxygenation using near infrared spectroscopy in preterm infants with persistent ductus arteriosus

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patent ductus arteriosus (PDA) is common in preterm infants. In the presence of a large PDA, significant systemic to pulmonary shunting occurs, which may result in pulmonary hyperperfusion and systemic hypoperfusion.

The evidence on PDA effect on brain and renal tissue oxygenation, measured by Near Infrared Spectroscopy is still controversial.

This study aims to evaluate the brain and renal oxygenation using near infrared spectroscopy (NONIN SenSmart model X-100) in 3 groups of preterm infants: 1) closed ductus arteriosus, 2) persistent ductus arteriosus, 3) hemodynamicaly significant ductus arteriosus.

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

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

Study Locations

  • Lithuania
      • Vilnius, Lithuania, 08406
        • Vilnius University Santaros Klinikos Neonatology Center

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

Non-Probability Sample

Study Population

Preterm infants with gestation age of < 32 weeks, birth weight < 1500g, > 72 hours of age, will have NIRS monitors placed to measure cerebral and renal regional tissue oxygenation.

Description

Inclusion Criteria:

  • preterm infants with gestation age of < 32 weeks
  • birth weight < 1500g
  • > 72 hours of age.

Exclusion Criteria:

  • cardiovascular, renal, cerebral congenital defects,
  • confirmed sepsis,
  • no parental consent

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group1
preterm infant with closed ductus arteriosus, <32 weeks birth weight < 1500g, and > 72 hours of age
Device: NONIN SenSmart model X-100 near- infrared spectrometer
for to measure cerebral (cSO2) and renal (rSO2 ) regional tissue oxygen saturation on the day after echocardiography was done. The sensors were placed on the right/left forehead and the right/left lateral posterior flank
Other Names:
  • GE LOGIQ S8 XDclear 2.0 ultrasoud
group2
preterm infant with PDA < 32 weeks, birth weight < 1500g, and > 72 hours of age
Device: NONIN SenSmart model X-100 near- infrared spectrometer
for to measure cerebral (cSO2) and renal (rSO2 ) regional tissue oxygen saturation on the day after echocardiography was done. The sensors were placed on the right/left forehead and the right/left lateral posterior flank
Other Names:
  • GE LOGIQ S8 XDclear 2.0 ultrasoud
group3
preterm infant with hemodynamically significant PDA < 32 weeks, birth weight < 1500g, and > 72 hours of age
Device: NONIN SenSmart model X-100 near- infrared spectrometer
for to measure cerebral (cSO2) and renal (rSO2 ) regional tissue oxygen saturation on the day after echocardiography was done. The sensors were placed on the right/left forehead and the right/left lateral posterior flank
Other Names:
  • GE LOGIQ S8 XDclear 2.0 ultrasoud

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences of the mean values of regional oxygenation of the brain and renal
Time Frame: from Day 4 of live up to 36 weeks
Cerebral and renal regional tissue oxygen saturation monitoring on the day after echocardiography was done
from Day 4 of live up to 36 weeks

Collaborators and Investigators

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

Sponsor

Vilnius University

Investigators

  • Study Director: Augustina Jankauskiene, MD, Vilnius University

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 (Actual)

November 9, 2017

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

November 30, 2021

Study Registration Dates

First Submitted

February 19, 2020

First Submitted That Met QC Criteria

March 3, 2020

First Posted (Actual)

March 4, 2020

Study Record Updates

Last Update Posted (Actual)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 3, 2023

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIRS-2017

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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