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NCT04295395 Clinical Trial

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

Pre-Term Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04295395
Other study ID # AIRS-2017
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 9, 2017
Est. completion date November 30, 2021

Study information
Verified date March 2021
Source Vilnius University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date November 30, 2021
Est. primary completion date November 30, 2021
Accepts healthy volunteers No
Gender All
Age group 22 Weeks to 32 Weeks
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Lithuania Vilnius University Santaros Klinikos Neonatology Center Vilnius

Sponsors (1)
Lead Sponsor Collaborator
Vilnius University

Country where clinical trial is conducted

Lithuania, 

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