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

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Patent ductus arteriosus
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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, j[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