Pre-TermNCT04295395
Evaluation of the Brain and Renal Regional Oxygenation Using NIRS in Preterm Infants
An observational study of Pre-Term and Persistent Ductus Arteriosus, run by Vilnius University at 1 site in Lithuania.
Trial summary
This study evaluates the brain and renal oxygenation using near infrared spectroscopy in preterm infants with persistent ductus arteriosus Read more about this study
- Who is it for?
- Ages 22 to 32 weeks
- Conditions the study is for
- Pre-Term, Persistent Ductus Arteriosus
- What is being tested?
- NONIN SenSmart model X-100 near- infrared spectrometer
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteLithuania
- Study dates
- 9 Nov 2017to 30 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 32 weeks
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- preterm infants with gestation age of < 32 weeks
- birth weight < 1500g
- > 72 hours of age.
Who cannot join
- cardiovascular, renal, cerebral congenital defects,
- confirmed sepsis,
- no parental consent
Trial locations and contacts
1 site in 1 country.
Lithuania1 site
Vilnius University Santaros Klinikos Neonatology Center
Vilnius, 08406
About this study
Official title: Evaluation of the Brain and Renal Regional Oxygenation Using Near Infrared Spectroscopy (NIRS) Method in Very Low Birth Weight (<1500 g) Infants
This study evaluates the brain and renal oxygenation using near infrared spectroscopy in preterm infants with persistent ductus arteriosus
Read the 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
- Being tested
- NONIN SenSmart model X-100 near- infrared spectrometer
- Keywords
- near-infrared spectroscopy, preterm infant, echocardiography
- Medical subject headings
- Premature Birth, Ductus Arteriosus, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NONIN SenSmart model X-100 near- infrared spectrometerDevice
Also called GE LOGIQ S8 XDclear 2.0 ultrasoud
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
| Study group | Role | What they receive |
|---|---|---|
| group1 | preterm infant with closed ductus arteriosus, <32 weeks birth weight < 1500g, and > 72 hours of age Receives: Device: NONIN SenSmart model X-100 near- infrared spectrometer | |
| group2 | preterm infant with PDA < 32 weeks, birth weight < 1500g, and > 72 hours of age Receives: 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 Receives: Device: NONIN SenSmart model X-100 near- infrared spectrometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from Day 4 of live up to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start9 Nov 2017
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre-TermStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Augustina Jankauskiene, MD, Study director, Vilnius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295395
- Sponsor's protocol ID
- AIRS-2017
- Status last verified
- Mar 2021
- First submitted
- 19 Feb 2020
- Last updated
- 4 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34886825
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Brain and Renal Regional Oxygenation Using Near Infrared Spectroscopy (NIRS) Method in Very Low Birth Weight (<1500 g) Infants
- ClinicalTrials.gov ID
- NCT04295395
- Acronym / sponsor ID
- AIRS-2017
- Conditions
- Pre-Term, Persistent Ductus Arteriosus
- Keywords
- near-infrared spectroscopy, preterm infant, echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Study start
- 9 Nov 2017 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 4 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group1 | – | Device: NONIN SenSmart model X-100 near- infrared spectrometerpreterm infant with closed ductus arteriosus, <32 weeks birth weight < 1500g, and > 72 hours of age |
| group2 | – | Device: NONIN SenSmart model X-100 near- infrared spectrometerpreterm infant with PDA < 32 weeks, birth weight < 1500g, and > 72 hours of age |
| group3 | – | Device: NONIN SenSmart model X-100 near- infrared spectrometerpreterm infant with hemodynamically significant PDA < 32 weeks, birth weight < 1500g, and > 72 hours of age |
Who may qualify
- Ages
- 22 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- preterm infants with gestation age of < 32 weeks
- birth weight < 1500g
- > 72 hours of age.
Key exclusion criteria (3 listed)
- cardiovascular, renal, cerebral congenital defects,
- confirmed sepsis,
- no parental consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NONIN SenSmart model X-100 near- infrared spectrometerAlso: GE LOGIQ S8 XDclear 2.0 ultrasoudfor 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 | Device | group1, group2, group3 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Derived from this study: PubMed 34886825Navikiene 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Augustina Jankauskiene, MD study director
Vilnius University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Term and Persistent Ductus Arteriosus, run by Vilnius University at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences of the mean values of regional oxygenation of the brain and renal (time frame: from Day 4 of live up to 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04295395, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.