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Clinical Trials/NCT04295395
NCT04295395
Completed
Not Applicable

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

Vilnius University1 site in 1 country150 target enrollmentNovember 9, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pre-Term
Sponsor
Vilnius University
Enrollment
150
Locations
1
Primary Endpoint
Differences of the mean values of regional oxygenation of the brain and renal
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
November 9, 2017
End Date
November 30, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Study Sites (1)

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