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

NCT ID: NCT04295395

Last Updated: 2023-01-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-09
• Study Completion Date: 2021-11-30

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.

Conditions

Pre-Term; Persistent Ductus Arteriosus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

group1

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

NONIN SenSmart model X-100 near- infrared spectrometer

Intervention Type: 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

group2

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

NONIN SenSmart model X-100 near- infrared spectrometer

Intervention Type: 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

group3

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

NONIN SenSmart model X-100 near- infrared spectrometer

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

GE LOGIQ S8 XDclear 2.0 ultrasoud

Eligibility Criteria

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

• Minimum Eligible Age: 22 Weeks
• Maximum Eligible Age: 32 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vilnius University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Augustina Jankauskiene, MD

Role: STUDY_DIRECTOR

Vilnius University

Locations

Vilnius University Santaros Klinikos Neonatology Center

Vilnius, , Lithuania

Countries

Lithuania

References

Navikiene J, Virsilas E, Vankeviciene R, Liubsys A, Jankauskiene A. Brain and renal oxygenation measured by NIRS related to patent ductus arteriosus in preterm infants: a prospective observational study. BMC Pediatr. 2021 Dec 9;21(1):559. doi: 10.1186/s12887-021-03036-w.

Reference Type: DERIVED

PMID: 34886825 (View on PubMed)

Other Identifiers

AIRS-2017

Identifier Type: -

Identifier Source: org_study_id