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

NCT04295395 | Completed

• 1 other identifier: AIRS-2017
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pre-Term; Persistent Ductus Arteriosus

Keywords

near-infrared spectroscopy; preterm infant; echocardiography

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

group1

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

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

group2

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

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

group3

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

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

Interventions

NONIN SenSmart model X-100 near- infrared spectrometer 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

Also known as: GE LOGIQ S8 XDclear 2.0 ultrasoud

group1; group2; group3

Eligibility Criteria

• Age: 22 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm infants with gestation age of \< 32 weeks, birth weight \< 1500g, \> 72 hours of age, will have NIRS monitors placed to measure cerebral and renal regional tissue oxygenation.

You may qualify if:

• preterm infants with gestation age of \< 32 weeks
• birth weight \< 1500g
• \> 72 hours of age.

You may not qualify if:

• cardiovascular, renal, cerebral congenital defects,
• confirmed sepsis,
• no parental consent

Sponsors & Collaborators

• Vilnius University: lead

Study Sites (1)

Vilnius University Santaros Klinikos Neonatology Center

Vilnius, 08406, Lithuania

Location

Related Publications (1)

• 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.

  PMID: 34886825 DERIVED

MeSH Terms

Conditions

Premature Birth; Ductus Arteriosus, Patent

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Augustina Jankauskiene, MD

  Vilnius University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: March 4, 2020
• Study Start: November 9, 2017
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: January 4, 2023

Record last verified: 2021-03

Locations

LI (1)