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

Vilnius University

Status: Completed

Conditions: Persistent Ductus Arteriosus; Pre-Term

Treatments: Device: NONIN SenSmart model X-100 near- infrared spectrometer

Study type: Observational

Funder types: Other

Identifiers

NCT04295395

AIRS-2017

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 22 to 32 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 3 patient groups

group1

Description:

preterm infant with closed ductus arteriosus, \<32 weeks birth weight \< 1500g, and \> 72 hours of age

Treatment:

Device: NONIN SenSmart model X-100 near- infrared spectrometer

group2

Description:

preterm infant with PDA \< 32 weeks, birth weight \< 1500g, and \> 72 hours of age

Treatment:

Device: NONIN SenSmart model X-100 near- infrared spectrometer

group3

Description:

preterm infant with hemodynamically significant PDA \< 32 weeks, birth weight \< 1500g, and \> 72 hours of age

Treatment:

Device: NONIN SenSmart model X-100 near- infrared spectrometer