Neonatal DiseasepNIRSNCT05896306
Cerebral Monitoring Using Pulsatile Near Infrared Spectroscopy in Neonates
An observational study of Neonatal Disease, run by Medical University of Graz at 1 site in Austria.
Trial summary
The transition from fetus to newborn is a complex physiological process. Monitoring this process to detect potential disruptions is critical but remains a challenge. Initial evaluation of neonates is usually based on visual inspection, palpation and/or auscultation, and response to stimuli. Read more about this study
- Who is it for?
- Ages 0 to 15 minutes
- Conditions the study is for
- Neonatal Disease
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 30 May 2023to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 to 15 minutes
- All sexes
- No healthy volunteers
- Child
Study population: Term and preterm neonates after birth.
Who may be able to join
- Term and preterm neonates observed routinely at the resuscitation desk
- Decision to conduct full life support
- Written parental informed consent
Who cannot join
- No decision to conduct full life support
- No written parental informed consent
- Congenital malformation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Division Neonatology, Dep. Pediatrics
Graz, Styria, 8036
Nariae Baik-Schneditz, MD.PhD., +4331638582677, nariae.baik@medunigraz.at
About this study
Official title: Assessment of Cerebral Monitoring Using the Pulsatile Near Infrared Spectroscopy in Neonates Immediately After Birth - a Prospective Observational Pilot Study
The transition from fetus to newborn is a complex physiological process. Monitoring this process to detect potential disruptions is critical but remains a challenge. Initial evaluation of neonates is usually based on visual inspection, palpation and/or auscultation, and response to stimuli. To objectify the condition of the newborn during this vulnerable transitional period, Virginia Apgar developed a clinical assessment-based scoring system called the Apgar Score, which is widely used around the world. However, there is significant inter-observer and intra-observer variability in clinical assessments using the Apgar score. To objectively assess the condition of the newborn, the latest guidelines for postnatal adaptation and resuscitation recommend the use of electrocardiography (ECG) and pulse oximetry in the delivery room in addition to clinical evaluation. These monitoring methods allow non-invasive continuous monitoring of SpO2 (Oxygen saturation) as well as heart rate (HR), but do not provide information about potentially compromised cardiovascular status, resulting in severely restricted oxygen transport to tissues.
Cerebral Oxygenation:
Read more
The brain is one of the most vulnerable organs to hypoxia during the postnatal adaptation period. The recommended routine monitoring during the neonatal transition is SpO2 and heart rate. Unfortunately, these parameters do not provide any information about cerebral blood flow or oxygen supply or brain activity. About 30% of premature babies develop cerebral hemorrhage in the first 3 days after birth. This can lead to the development of hydrocephalus, poor neurological outcome and even death. For the above reasons, there is increasing interest in additional brain monitoring. Our research group has already shown in various studies that additional cerebral monitoring using near-infrared spectroscopy (NIRS) is possible in newborns immediately after birth and may be beneficial during this vulnerable phase of life. Furthermore, this add-on monitoring could inform interventions to optimize brain oxygenation, potentially affecting survival with improved short- and long-term neurological outcomes.
Background:
The transition from fetus to newborn is a complex physiological process. Monitoring this process to detect potential disruptions is critical but remains a challenge. Initial evaluation of neonates is usually based on visual inspection, palpation and/or auscultation, and response to stimuli. To objectify the condition of the newborn during this vulnerable transitional period, Virginia Apgar developed a clinical assessment-based scoring system called the Apgar Score, which is widely used around the world. However, there is significant inter-observer and intra-observer variability in clinical assessments using the Apgar score. To objectively assess the condition of the newborn, the latest guidelines for postnatal adaptation and resuscitation recommend the use of electrocardiography (ECG) and pulse oximetry in the delivery room in addition to clinical evaluation. These monitoring methods allow non-invasive continuous monitoring of SpO2 as well as HR, but do not provide information about potentially compromised cardiovascular status, resulting in severely restricted oxygen transport to tissues.
Pulsatile mode of NIRS Recently, Hamamatsu developed new software and implemented it as a pulsatile mode in one of their near-infrared spectroscopy (NIRS) instruments, the NIRO 200 NX. In contrast to the conventional NIRS technique, which measures tissue saturation closer to venous oxygen saturation than arterial oxygen saturation, the pulsatile NIRS technique uses a higher measurement rate of 20 Hertz and can therefore measure cerebral pulse rate (cPR) and cerebral arterial oxygen saturation (SnO2) in small vessels.
Using the non-invasive pulsatile NIRS technique could be a viable new method to continuously monitor blood flow to the brain during resuscitation. This can be particularly beneficial for critically ill newborns and premature babies.
To date, no data have been published in neonates using the pulsatile NIRS technique.
- Conditions
- Neonatal Disease
- Being tested
- No intervention
- Keywords
- pNIRS, Neonates, Postnatal transition
- Medical subject headings
- Infant, Newborn, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Term neonates | Not described Receives: Other: No intervention | |
| Preterm neonates | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of cerebral oxygenation in cerebral pusatile vessels
cerebral oxygenation in pusatile vessels (SnO2)
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start30 May 2023
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896306
- Sponsor's protocol ID
- 35-281 ex 22/23
- Acronym
- pNIRS
- Status last verified
- Oct 2026
- First submitted
- 31 May 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cerebral Monitoring Using the Pulsatile Near Infrared Spectroscopy in Neonates Immediately After Birth - a Prospective Observational Pilot Study
- ClinicalTrials.gov ID
- NCT05896306
- Acronym / sponsor ID
- pNIRS / 35-281 ex 22/23
- Conditions
- Neonatal Disease
- Keywords
- pNIRS, Neonates, Postnatal transition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 30 May 2023 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 9 Jun 2023 (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.
The transition from fetus to newborn is a complex physiological process. Monitoring this process to detect potential disruptions is critical but remains a challenge. Initial evaluation of neonates is usually based on visual inspection, palpation and/or auscultation, and response to stimuli. To objectify the condition of the newborn during this vulnerable transitional period, Virginia Apgar developed a clinical assessment-based scoring system called the Apgar Score, which is widely used around the world. However, there is significant inter-observer and intra-observer variability in clinical assessments using the Apgar score. To objectively assess the condition of the newborn, the latest guidelines for postnatal adaptation and resuscitation recommend the use of electrocardiography (ECG) and pulse oximetry in the delivery room in addition to clinical evaluation. These monitoring methods allow non-invasive continuous monitoring of SpO2 (Oxygen saturation) as well as heart rate (HR), but do not provide information about potentially compromised cardiovascular status, resulting in severely restricted oxygen transport to tissues.
Cerebral Oxygenation:
The brain is one of the most vulnerable organs to hypoxia during the postnatal adaptation period. The recommended routine monitoring during the neonatal transition is SpO2 and heart rate. Unfortunately, these parameters do not provide any information about cerebral blood flow or oxygen supply or brain activity. About 30% of premature babies develop cerebral hemorrhage in the first 3 days after birth. This can lead to the development of hydrocephalus, poor neurological outcome and even death. For the above reasons, there is increasing interest in additional brain monitoring. Our research group has already shown in various studies that additional cerebral monitoring using near-infrared spectroscopy (NIRS) is possible in newborns immediately after birth and may be beneficial during this vulnerable phase of life. Furthermore, this add-on monitoring could inform interventions to optimize brain oxygenation, potentially affecting survival with improved short- and long-term neurological outcomes.
Background:
The transition from fetus to newborn is a complex physiological process. Monitoring this process to detect potential disruptions is critical but remains a challenge. Initial evaluation of neonates is usually based on visual inspection, palpation and/or auscultation, and response to stimuli. To objectify the condition of the newborn during this vulnerable transitional period, Virginia Apgar developed a clinical assessment-based scoring system called the Apgar Score, which is widely used around the world. However, there is significant inter-observer and intra-observer variability in clinical assessments using the Apgar score. To objectively assess the condition of the newborn, the latest guidelines for postnatal adaptation and resuscitation recommend the use of electrocardiography (ECG) and pulse oximetry in the delivery room in addition to clinical evaluation. These monitoring methods allow non-invasive continuous monitoring of SpO2 as well as HR, but do not provide information about potentially compromised cardiovascular status, resulting in severely restricted oxygen transport to tissues.
Pulsatile mode of NIRS Recently, Hamamatsu developed new software and implemented it as a pulsatile mode in one of their near-infrared spectroscopy (NIRS) instruments, the NIRO 200 NX. In contrast to the conventional NIRS technique, which measures tissue saturation closer to venous oxygen saturation than arterial oxygen saturation, the pulsatile NIRS technique uses a higher measurement rate of 20 Hertz and can therefore measure cerebral pulse rate (cPR) and cerebral arterial oxygen saturation (SnO2) in small vessels.
Using the non-invasive pulsatile NIRS technique could be a viable new method to continuously monitor blood flow to the brain during resuscitation. This can be particularly beneficial for critically ill newborns and premature babies.
To date, no data have been published in neonates using the pulsatile NIRS technique.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Term neonates | – | Other: No intervention |
| Preterm neonates | – | Other: No intervention |
Who may qualify
- Ages
- 0 to 15 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Term and preterm neonates after birth.
Key inclusion criteria (3 listed)
- Term and preterm neonates observed routinely at the resuscitation desk
- Decision to conduct full life support
- Written parental informed consent
Key exclusion criteria (3 listed)
- No decision to conduct full life support
- No written parental informed consent
- Congenital malformation
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 |
|---|---|---|
| No interventionNo intervention | Other | Preterm neonates, Term neonates |
Primary outcome
Percentage of cerebral oxygenation in cerebral pusatile vessels
Time frame: 15 minutes
cerebral oxygenation in pusatile vessels (SnO2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Neonatal Disease, run by Medical University of Graz at 1 site in Austria.
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: looking for participants now, as of the sponsor's last update on 20 Oct 2026. 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 Austria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nariae Baik-Schneditz, MD. PhD (+4331638582677, nariae.baik@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of cerebral oxygenation in cerebral pusatile vessels (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2026.