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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04295395
Enrollment
150
Registered
2020-03-04
Start date
2017-11-09
Completion date
2021-11-30
Last updated
2023-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent Ductus Arteriosus, Pre-Term

Keywords

near-infrared spectroscopy, preterm infant, echocardiography

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.

Interventions

DEVICENONIN 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

Sponsors

Vilnius University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
22 Weeks to 32 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Differences of the mean values of regional oxygenation of the brain and renalfrom Day 4 of live up to 36 weeksCerebral and renal regional tissue oxygen saturation monitoring on the day after echocardiography was done

Countries

Lithuania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026