POP-Score: A simple, non-invasive test to see if newborns might have early infection
Official title: The Peripheral(-Muscle) Oxygenation and Perfusion Score (POPScore) a New Non-invasive Tool to Predict Elevations in C-reactive Protein Levels in Neonates - a Prospective Phase II Observational Study
Run by Medical University of Graz · NCT07109856 · Data updated 2026-11-12
This study tests whether the POP-Score, a non-invasive measure using NIRS and routine vitals, can predict elevated CRP in term and near-term neonates within 48 hours of birth.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 0 Hours to 6 Hours |
| Sex | All |
| Enrollment | 93 (estimated) |
| Sponsor | Medical University of Graz Academic / other |
| Locations | 1 site (Graz, Styria) |
| Status | Recruiting |
| Started | November 27, 2025 |
| Main results expected | March 1, 2028 |
| Study ends | May 1, 2028 |
| Registry record updated | May 14, 2026 |
| Trial ID | NCT07109856 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Term or moderate-to-late preterm neonates (birth weight ≥2000 g) with respiratory distress and risk factors for infection, whose guardians provide consent within 6 hours of birth.
✕Probably not a fit
Neonates without infection risk factors or whose CRP would not elevate despite other illness may not benefit from POP-Score findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, single-center observational study at the Medical University of Graz. It evaluates whether the Peripheral(-muscle) Oxygenation and Perfusion Score (POP-Score), which combines peripheral muscle oxygenation from NIRS with heart rate, oxygen saturation, systolic blood pressure, and skin fat thickness, can predict CRP elevations (≥20 mg/L) within 48 hours after birth. Measurements include multi-site NIRS data (cerebral, peripheral muscle, intestinal, and flank) collected in neonates with respiratory distress and risk factors for infection. Eligible infants are term or moderate-to-late preterm with birth weight ≥2000 g and parental consent obtained within the first 6 hours of life. The study aims to establish an optimal POP-Score cut-off within 6 hours post-birth for early infection screening.
Why it matters
Potential benefit: If successful, this approach could enable earlier identification of infection or inflammation in newborns using a non-invasive score.
How similar studies have gone: Prior pilot data suggested high sensitivity and good specificity for predicting elevated CRP with the POP-Score, supporting further validation in a larger cohort.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Medical University of Graz, Division of Neonatology
Graz, Styria, Austria Recruiting
Study contacts
- Study coordinator: Christina H. Wolfsberger, MD, PhD
- Email: christina.wolfsberger@medunigraz.at
- Phone: +43 316 385 81135
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.