Evaluation of the Brain and Renal Regional Oxygenation Using Near Infrared Spectroscopy (NIRS) Method in Very Low Birth Weight (<1500 g) Infants
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Vilnius University
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Differences of the mean values of regional oxygenation of the brain and renal
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 22 Weeks to 32 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Differences of the mean values of regional oxygenation of the brain and renal
Time Frame: from Day 4 of live up to 36 weeks
Cerebral and renal regional tissue oxygen saturation monitoring on the day after echocardiography was done
Secondary Outcomes
No secondary outcomes reported