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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Persistent Ductus Arteriosus
• Pre-Term

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