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

Completed
Conditions
Persistent Ductus Arteriosus
Pre-Term
Registration Number
NCT04295395
Lead Sponsor
Vilnius University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
150
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

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Differences of the mean values of regional oxygenation of the brain and renalfrom Day 4 of live up to 36 weeks

Cerebral and renal regional tissue oxygen saturation monitoring on the day after echocardiography was done

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Vilnius University Santaros Klinikos Neonatology Center

🇱🇹

Vilnius, Lithuania

Vilnius University Santaros Klinikos Neonatology Center
🇱🇹Vilnius, Lithuania

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