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Completed

NCT Number: NCT04295395

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

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

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Key information

Conditions

Pre-Term Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Ductus Arteriosus, Patent Female Urogenital Diseases and Pregnancy Complications Heart Defects, Congenital Heart Diseases Obstetric Labor Complications Obstetric Labor, Premature Persistent Ductus Arteriosus Pregnancy Complications Premature Birth Urogenital Diseases

Age range

22 week–32 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Vilnius University Santaros Klinikos Neonatology Center

Vilnius, 08406, Lithuania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NONIN SenSmart model X-100 near- infrared spectrometer

Device

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Vilnius University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 4, 2020
Registry last updated
Jan 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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