Actively Recruiting
Assessment of Cerebral Monitoring Using the Pulsatile Near Infrared Spectroscopy in Neonates Immediately After Birth - a Prospective Observational Pilot Study
Led by Medical University of Graz · Updated on 2025-11-19
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
The transition from fetus to newborn is a complex process that requires careful monitoring to detect any problems early. This trial focuses on neonatal disease by evaluating cerebral monitoring using a new pulsatile near-infrared spectroscopy (NIRS) method immediately after birth. Traditional methods like the Apgar score and standard monitoring of oxygen saturation and heart rate have limitations, especially in assessing brain oxygenation and blood flow during this critical time. The study is observational and aims to explore this innovative approach in newborns, including both term and preterm infants. The new pulsatile NIRS technique, used with the NIRO 200 NX device, measures cerebral pulse rate and arterial oxygen saturation in small brain vessels continuously and non-invasively. Unlike conventional NIRS, it captures data at a higher rate to provide better insight into brain oxygenation and blood flow. The study involves no intervention and observes neonates routinely at the resuscitation desk, with groups including term and preterm babies. This method could help identify brain oxygen supply issues early and guide potential interventions in the future. Participants, both term and preterm neonates, will be monitored right after birth during routine care at the resuscitation station. Researchers will measure the percentage of cerebral oxygenation in pulsatile cerebral vessels over 15 minutes. No active treatments are given as part of the study. The goal is to collect data that may improve understanding of brain oxygen delivery during the vulnerable newborn transition. The study requires parental consent and includes follow-up to ensure safety and accurate data collection during this early period of life.
CONDITIONS
Brief Title
Cerebral Monitoring Using Pulsatile Near Infrared Spectroscopy in Neonates
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Term and preterm neonates observed routinely at the resuscitation desk
- Decision to conduct full life support
- Written parental informed consent
You will not qualify if you...
- No decision to conduct full life support
- No written parental informed consent
- Congenital malformation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 15 minutes
Participants undergo cerebral monitoring using pulsatile near infrared spectroscopy immediately after birth.
1 assessment immediately after birth
Duration - Up to hospital discharge
Participants are observed routinely after the initial cerebral monitoring without any intervention.
Observation during routine care
Trial Site Locations
Total: 1 location
1
Division Neonatology, Dep. Pediatrics
Graz, Styria, Austria, 8036
Actively Recruiting
Research Team
N
Nariae Baik-Schneditz, MD. PhD
B
Bernhard Schwaberger, MD.PhD.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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