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

Completed

• Conditions: Persistent Ductus Arteriosus; Pre-Term
• Interventions: Device: NONIN SenSmart model X-100 near- infrared spectrometer

• 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.

Study Timeline

• Study Start: 2017-11-09
• Study First Submitted: 2020-02-19
• Study First Submitted QC: 2020-03-03
• Study First Posted: 2020-03-04
• Status Verified: 2021-03
• Primary Completion: 2021-11-30
• Study Completion: 2021-11-30
• Last Update Submitted: 2023-01-03
• Last Update Posted: 2023-01-04

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

Arm && Interventions

Group	Intervention	Description
group2	NONIN SenSmart model X-100 near- infrared spectrometer	preterm infant with PDA \< 32 weeks, birth weight \< 1500g, and \> 72 hours of age
group1	NONIN SenSmart model X-100 near- infrared spectrometer	preterm infant with closed ductus arteriosus, \<32 weeks birth weight \< 1500g, and \> 72 hours of age
group3	NONIN SenSmart model X-100 near- infrared spectrometer	preterm infant with hemodynamically significant PDA \< 32 weeks, birth weight \< 1500g, and \> 72 hours of age

Primary Outcome Measures

Name	Time	Method
Differences of the mean values of regional oxygenation of the brain and renal	from Day 4 of live up to 36 weeks	Cerebral and renal regional tissue oxygen saturation monitoring on the day after echocardiography was done

Trial Locations

Locations (1)

Vilnius University Santaros Klinikos Neonatology Center; 🇱🇹 Vilnius, Lithuania