NCT07109856 The Peripheral(-Muscle) Oxygenation and Perfusion Score as a New Non-invasive Tool to Predict Elevations in C-reactive Protein Levels in Neonates
| NCT ID | NCT07109856 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Graz |
| Condition | Prematurity, Infections |
| Study Type | OBSERVATIONAL |
| Enrollment | 93 participants |
| Start Date | 2025-11-27 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 93 participants in total. It began in 2025-11-27 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective, single-center Phase II observational study investigating the predictive value of the "Peripheral(-muscle) Oxygenation and Perfusion Score" (POP-Score), a novel non-invasive composite index, for early detection of infection/inflammation in neonates. The POP-Score combines peripheral muscle oxygenation measured via near-infrared spectroscopy (NIRS) with routinely monitored clinical parameters (heart rate, oxygen saturation, systolic blood pressure, and subcutaneous fat thickness). The study aims to determine the optimal cut-off value of the POP-Score measured within the first 6 hours after birth to predict elevated C-reactive protein (CRP ≥20 mg/L) within 48 hours. Additionally, multi-site NIRS measurements (cerebral, peripheral muscle, intestinal, and flank) will be evaluated to assess their association with inflammation. The study includes term and moderate-to-late preterm neonates (birth weight ≥2000g) with respiratory distress, admitted to the neonatal intensive care unit at the Medical University of Graz.
Eligibility Criteria
Inclusion Criteria: * birth weight ≥ 2000 grams * Signs of respiratory distress at time-point of inclusion (tachypnoea \>60/min, grunting, intercostal/subcostal/jugular retractions, nasal flaring, supplemental oxygen or respiratory support) * Decision to conduct full life support * Written informed consent obtained within the first 6 hours after birth, before inclusion in the study * Age \< 6 hours Exclusion Criteria: * No decision to conduct full life support * No written informed consent * Birth weight \< 2000 grams * Age \> 6 hours * Severe congenital malformations, * Umbilical cord artery pH \<7.20
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07109856 clinical trial?
This trial is open to participants of all sexes, aged 0 Hours or older, up to 6 Hours, studying Prematurity, Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07109856 currently recruiting?
Yes, NCT07109856 is actively recruiting participants. Contact the research team at christina.wolfsberger@medunigraz.at for enrollment information.
Where is the NCT07109856 trial being conducted?
This trial is being conducted at Graz, Austria.
Who is sponsoring the NCT07109856 clinical trial?
NCT07109856 is sponsored by Medical University of Graz. The trial plans to enroll 93 participants.