Brief Title
Evaluation of the Brain and Renal Regional Oxygenation Using NIRS in Preterm Infants
Official Title
Evaluation of the Brain and Renal Regional Oxygenation Using Near Infrared Spectroscopy (NIRS) Method in Very Low Birth Weight (<1500 g) Infants
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 Type
Observational
Primary Outcome
Differences of the mean values of regional oxygenation of the brain and renal
Condition
Pre-Term
Intervention
NONIN SenSmart model X-100 near- infrared spectrometer
Study Arms / Comparison Groups
group1
Description: preterm infant with closed ductus arteriosus, <32 weeks birth weight < 1500g, and > 72 hours of age
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
150
Start Date
November 9, 2017
Completion Date
November 2021
Primary Completion Date
November 2021
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
Gender
All
Ages
22 Weeks - 32 Weeks
Accepts Healthy Volunteers
No
Contacts
Augustina Jankauskiene, MD, +37069882515, [email protected]
Location Countries
Lithuania
Location Countries
Lithuania
Administrative Informations
NCT ID
NCT04295395
Organization ID
AIRS-2017
Responsible Party
Sponsor
Study Sponsor
Vilnius University
Study Sponsor
Augustina Jankauskiene, MD, Study Director, Vilnius University
Verification Date
March 2020