Prematurity, InfectionsPOP-ScoreNCT07109856
The Peripheral(-Muscle) Oxygenation and Perfusion Score as a New Non-invasive Tool to Predict Elevations in C-reactive Protein Levels in Neonates
An observational study of Prematurity, Infections and NIRS, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 6 hours
- Conditions the study is for
- Prematurity, Infections, NIRS, Near Infrared Spectroscopy
- What is being tested?
- POP-Score Assessment and Near-Infrared Spectroscopy (NIRS)
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 93 participants
- Where
- 1 siteAustria
- Study dates
- 27 Nov 2025to 1 May 2028
- 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 6 hours
- All sexes
- No healthy volunteers
- Child
Study population: Term and moderate-to-late preterm neonates (birth weight ≥ 2000 grams) with signs of respiratory distress within the first 6 hours after birth, admitted to the neonatal intensive care unit at the Medical University of Graz. All participants must have a gestational age allowing for clinical stability and must meet inclusion criteria including full life support decision and informed consent obtained within 6 hours of birth.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gerhard Pichler, Prof contact
Austria1 site, 1 recruiting
- Recruiting
Medical University of Graz, Division of Neonatology
Graz, Styria, 8036
About this study
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
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.
Read the detailed description
Early identification of neonatal infection and inflammation remains a major challenge in neonatal intensive care, particularly in term and moderate-to-late preterm infants with respiratory distress. Current diagnostic approaches rely heavily on clinical symptoms and laboratory markers, which may be subtle or delayed. This study evaluates the diagnostic potential of a novel, non-invasive scoring system-the Peripheral(-muscle) Oxygenation and Perfusion Score (POP-Score)-in predicting elevated C-reactive protein (CRP) levels (≥20 mg/L) within 48 hours after birth.
The POP-Score integrates near-infrared spectroscopy (NIRS)-based peripheral muscle tissue oxygenation measurements (pTOI) with standard clinical monitoring parameters: arterial oxygen saturation (SpO2), heart rate (HR), systolic arterial blood pressure (SABP), and subcutaneous fat layer thickness (measured by ultrasound). A pilot study demonstrated that a POP-Score >1.00 within 6 hours after birth had high sensitivity (100%) and specificity (87%) in predicting elevated CRP values, suggesting potential for early infection screening.
This is a prospective, single-center, observational Phase II study conducted at the Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz, Austria. Term and moderate-to-late preterm neonates (birth weight ≥2000g) with respiratory distress and risk factors for infection are eligible. Exclusion criteria include severe congenital anomalies, birth weight <2000g, age >6 hours at time of consent, or umbilical artery pH <7.20.
NIRS measurements will be performed within the first 6 hours after birth at four anatomical sites: peripheral muscle (right forearm), cerebral (left forehead), intestinal (infraumbilical), and flank (left posterior flank at T12-L2). Each site will be measured five times using short-duration sensor reapplications to improve data precision. Concurrently, SpO2 and HR (via pulse oximetry), blood pressure, temperature, and subcutaneous fat thickness (via ultrasound) will be recorded. CRP and other laboratory parameters (including leukocyte count, IT-ratio) will be obtained as part of routine care on the first and second day after birth.
The primary aim is to identify the optimal cut-off level of the POP-Score, calculated within the first 6 hours, to predict CRP ≥20 mg/L within 48 hours. Receiver Operating Characteristic (ROC) analysis will be used, with the area under the curve (AUC) estimated and the optimal cut-off determined via the Youden Index.
Secondary aims include evaluating whether multi-site NIRS measurements (cerebral, peripheral muscle, intestinal, and flank) differ significantly between neonates with CRP ≥20 mg/L and those with CRP <20 mg/L, potentially offering additional early indicators of infection or inflammation.
The target sample size is 93 neonates, assuming a 20% incidence of CRP ≥20 mg/L. This allows estimation of the AUC with a 95% confidence interval and acceptable precision. Data will be analyzed using appropriate statistical tests for categorical and continuous variables. Statistical analyses will be conducted in cooperation with the Institute for Medical Informatics, Statistics, and Documentation, Medical University of Graz.
The POP-Score and multi-site NIRS monitoring offer a potentially powerful, non-invasive approach for early identification of at-risk neonates, enabling earlier intervention and improved outcomes. If validated, this tool may support more accurate and timely clinical decision-making in neonatal intensive care settings.
- Conditions
- Prematurity, Infections, NIRS, Near Infrared Spectroscopy, Preterm Neonates, Term Infant, Infection
- Being tested
- POP-Score Assessment, Near-Infrared Spectroscopy (NIRS)
- Keywords
- NIRS, near-infrared spectroscopy, POP-Score, neonates, preterm neonates
- Medical subject headings
- Premature Birth, Infections, Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POP-Score AssessmentDiagnostic test
A non-invasive score calculated within the first 6 hours after birth using peripheral muscle oxygenation (pTOI, measured via near-infrared spectroscopy), heart rate, arterial oxygen saturation (SpO2), systolic blood pressure (SABP), and subcutaneous fat layer thickness. The score is evaluated for its ability to predict C-reactive protein (CRP) levels ≥ 20 mg/L within 48 hours.
Near-Infrared Spectroscopy (NIRS)Device
NIRS measurements are performed within 6 hours after birth using the NIRO 200NX device at four anatomical sites (forearm, forehead, infraumbilical region, and left flank). Measurements assess peripheral muscle, cerebral, intestinal, and flank oxygenation to identify possible differences in tissue perfusion associated with early inflammation or infection.
| Study group | Role | What they receive |
|---|---|---|
| Observational cohort | This cohort includes term and moderate-to-late preterm neonates (birth weight ≥ 2000g) with respiratory distress within the first 6 hours after birth, admitted to the neonatal intensive care unit. All enrolled neonates undergo non-invasive monitoring to assess the predictive value of the POP-Score for identifying elevated CRP (≥20 mg/L) within the first 48 hours after birth. The cohort will also be analyzed to evaluate differences in multi-site NIRS measurements (peripheral muscle, cerebral, intestinal, and flank) between those with and without CRP elevation. Receives: Diagnostic Test: POP-Score Assessment; Device: Near-Infrared Spectroscopy (NIRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal Cut-Off Value of the POP-Score to Predict Elevated CRP (≥ 20 mg/L)
Determine the optimal cut-off value of the non-invasive POP-Score (unitless score), measured within the first 6 hours after birth, to predict elevated C-reactive protein (CRP) levels (≥ 20 mg/L) within the first 48 hours after birth in neonates with respiratory distress.
Measured: Within the first 6 hours after birth (parameters of the POP-Score) and CRP within 48 hours
Secondary outcomes (4)
Difference in Peripheral Muscle Tissue Oxygenation by NIRS Between Neonates With and Without Elevated CRP
Evaluate whether there are significant differences in peripheral muscle tissue oxygenation values measured via near-infrared spectroscopy (NIRS) within the first 6 hours after birth between neonates with elevated CRP levels (≥ 20 mg/L) and those with CRP < 20 mg/L.
Unit of Measure: % tissue oxygen saturation
Measured: NIRS within 6 hours after birth; CRP within 48 hours
Difference in Cerebral Tissue Oxygenation by NIRS Between Neonates With and Without Elevated CRP
Evaluate whether there are significant differences in cerebral tissue oxygenation values measured via near-infrared spectroscopy (NIRS) within the first 6 hours after birth between neonates with elevated CRP levels (≥ 20 mg/L) and those with CRP < 20 mg/L.
Unit of Measure: % tissue oxygen saturation
Measured: NIRS within 6 hours after birth; CRP within 48 hours
Difference in Intestinal Tissue Oxygenation by NIRS Between Neonates With and Without Elevated CRP
Evaluate whether there are significant differences in intestinal tissue oxygenation values measured via near-infrared spectroscopy (NIRS) within the first 6 hours after birth between neonates with elevated CRP levels (≥ 20 mg/L) and those with CRP < 20 mg/L.
Unit of Measure: % tissue oxygen saturation
Measured: NIRS within 6 hours after birth; CRP within 48 hours
Difference in Flank Tissue Oxygenation by NIRS Between Neonates With and Without Elevated CRP
Evaluate whether there are significant differences in flank tissue oxygenation values measured via near-infrared spectroscopy (NIRS) within the first 6 hours after birth between neonates with elevated CRP levels (≥ 20 mg/L) and those with CRP < 20 mg/L.
Unit of Measure: % tissue oxygen saturation
Measured: NIRS within 6 hours after birth; CRP within 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start27 Nov 2025
- Primary completion1 Mar 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Prematurity, InfectionsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Wolfsberger, MD, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109856
- Sponsor's protocol ID
- POP-Score
- Other IDs
- Ethical board number 1010/2025
- Acronym
- POP-Score
- Status last verified
- May 2026
- First submitted
- 31 Jul 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pichler G, Pocivalnik M, Riedl R, Pichler-Stachl E, Zotter H, Muller W, Urlesberger B. C reactive protein: impact on peripheral tissue oxygenation and perfusion in neonates. Arch Dis Child Fetal Neonatal Ed. 2012 Nov;97(6):F444-8. doi: 10.1136/archdischild-2011-300578. Epub 2012 Jan 31.
PubMed 22294473Nanas S, Gerovasili V, Renieris P, Angelopoulos E, Poriazi M, Kritikos K, Siafaka A, Baraboutis I, Zervakis D, Markaki V, Routsi C, Roussos C. Non-invasive assessment of the microcirculation in critically ill patients. Anaesth Intensive Care. 2009 Sep;37(5):733-9. doi: 10.1177/0310057X0903700516.
PubMed 19775036Chiesa C, Pellegrini G, Panero A, Osborn JF, Signore F, Assumma M, Pacifico L. C-reactive protein, interleukin-6, and procalcitonin in the immediate postnatal period: influence of illness severity, risk status, antenatal and perinatal complications, and infection. Clin Chem. 2003 Jan;49(1):60-8. doi: 10.1373/49.1.60.
PubMed 12507961Pichler G, Holler N, Baik-Schneditz N, Schwaberger B, Mileder L, Stadler J, Avian A, Pansy J, Urlesberger B. Avoiding Arterial Hypotension in Preterm Neonates (AHIP)-A Single Center Randomised Controlled Study Investigating Simultaneous Near Infrared Spectroscopy Measurements of Cerebral and Peripheral Regional Tissue Oxygenation and Dedicated Interventions. Front Pediatr. 2018 Feb 1;6:15. doi: 10.3389/fped.2018.00015. eCollection 2018.
PubMed 29450194Grossauer K, Pichler G, Schmolzer G, Zotter H, Mueller W, Urlesberger B. Comparison of peripheral and cerebral tissue oxygenation index in neonates. Arch Dis Child Fetal Neonatal Ed. 2009 Mar;94(2):F156. doi: 10.1136/adc.2008.146654. No abstract available.
PubMed 19240298Pichler G, Grossauer K, Klaritsch P, Kutschera J, Zotter H, Muller W, Urlesberger B. Peripheral oxygenation in term neonates. Arch Dis Child Fetal Neonatal Ed. 2007 Jan;92(1):F51-2. doi: 10.1136/adc.2005.089037.
PubMed 17185431Pichler G, Pocivalnik M, Riedl R, Pichler-Stachl E, Morris N, Zotter H, Muller W, Urlesberger B. 'Multi-associations': predisposed to misinterpretation of peripheral tissue oxygenation and circulation in neonates. Physiol Meas. 2011 Aug;32(8):1025-34. doi: 10.1088/0967-3334/32/8/003. Epub 2011 Jun 7.
PubMed 21654025Pichler G, Wolf M, Roll C, Weindling MA, Greisen G, Wardle SP, Zaramella P, Naulaers G, Pellicer A, Austin T, Bartocci M, Urlesberger B. Recommendations to increase the validity and comparability of peripheral measurements by near infrared spectroscopy in neonates. 'Round table', section of haematology, oxygen transport and microcirculation, 48th annual meeting of ESPR, Prague 2007. Neonatology. 2008;94(4):320-2. doi: 10.1159/000151655. Epub 2008 Sep 11.
PubMed 18784432Holler N, Urlesberger B, Mileder L, Baik N, Schwaberger B, Pichler G. Peripheral Muscle Near-Infrared Spectroscopy in Neonates: Ready for Clinical Use? A Systematic Qualitative Review of the Literature. Neonatology. 2015;108(4):233-45. doi: 10.1159/000433515. Epub 2015 Aug 25.
PubMed 26338668Wolfsberger CH, Hoeller N, Baik-Schneditz N, Schwaberger B, Suppan E, Mileder LP, Avian A, Schlatzer C, Urlesberger B, Pichler G. Reference ranges of peripheral-muscle oxygenation in term neonates delivered by Caesarean section during immediate transition after birth. Acta Paediatr. 2024 Dec;113(12):2582-2589. doi: 10.1111/apa.17376. Epub 2024 Aug 8.
PubMed 39115093Wolfsberger CH, Holler N, Baik-Schneditz N, Schwaberger B, Suppan E, Mileder L, Avian A, Urlesberger B, Pichler G. Peripheral muscle fractional tissue oxygen extraction in stable term and preterm neonates during the first 24 h after birth. Front Pediatr. 2023 Nov 15;11:1276769. doi: 10.3389/fped.2023.1276769. eCollection 2023.
PubMed 38034828Pichler G, Binder C, Avian A, Beckenbach E, Schmolzer GM, Urlesberger B. Reference ranges for regional cerebral tissue oxygen saturation and fractional oxygen extraction in neonates during immediate transition after birth. J Pediatr. 2013 Dec;163(6):1558-63. doi: 10.1016/j.jpeds.2013.07.007. Epub 2013 Aug 22.
PubMed 23972642Naulaers G, Morren G, Van Huffel S, Casaer P, Devlieger H. Cerebral tissue oxygenation index in very premature infants. Arch Dis Child Fetal Neonatal Ed. 2002 Nov;87(3):F189-92. doi: 10.1136/fn.87.3.f189.
PubMed 12390989Bailey SM, Hendricks-Munoz KD, Mally P. Cerebral, renal, and splanchnic tissue oxygen saturation values in healthy term newborns. Am J Perinatol. 2014 Apr;31(4):339-44. doi: 10.1055/s-0033-1349894. Epub 2013 Jul 19.
PubMed 23873114Alderliesten T, Dix L, Baerts W, Caicedo A, van Huffel S, Naulaers G, Groenendaal F, van Bel F, Lemmers P. Reference values of regional cerebral oxygen saturation during the first 3 days of life in preterm neonates. Pediatr Res. 2016 Jan;79(1-1):55-64. doi: 10.1038/pr.2015.186. Epub 2015 Sep 21.
PubMed 26389823
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07109856
- Acronym / sponsor ID
- POP-Score / POP-Score
- Conditions
- Prematurity, Infections, NIRS, Near Infrared Spectroscopy, Preterm Neonates, Term Infant, Infection
- Keywords
- NIRS, near-infrared spectroscopy, POP-Score, neonates, preterm neonates
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 27 Nov 2025 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 7 Aug 2025 (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 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.
Detailed description
Early identification of neonatal infection and inflammation remains a major challenge in neonatal intensive care, particularly in term and moderate-to-late preterm infants with respiratory distress. Current diagnostic approaches rely heavily on clinical symptoms and laboratory markers, which may be subtle or delayed. This study evaluates the diagnostic potential of a novel, non-invasive scoring system-the Peripheral(-muscle) Oxygenation and Perfusion Score (POP-Score)-in predicting elevated C-reactive protein (CRP) levels (≥20 mg/L) within 48 hours after birth.
The POP-Score integrates near-infrared spectroscopy (NIRS)-based peripheral muscle tissue oxygenation measurements (pTOI) with standard clinical monitoring parameters: arterial oxygen saturation (SpO2), heart rate (HR), systolic arterial blood pressure (SABP), and subcutaneous fat layer thickness (measured by ultrasound). A pilot study demonstrated that a POP-Score >1.00 within 6 hours after birth had high sensitivity (100%) and specificity (87%) in predicting elevated CRP values, suggesting potential for early infection screening.
This is a prospective, single-center, observational Phase II study conducted at the Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz, Austria. Term and moderate-to-late preterm neonates (birth weight ≥2000g) with respiratory distress and risk factors for infection are eligible. Exclusion criteria include severe congenital anomalies, birth weight <2000g, age >6 hours at time of consent, or umbilical artery pH <7.20.
NIRS measurements will be performed within the first 6 hours after birth at four anatomical sites: peripheral muscle (right forearm), cerebral (left forehead), intestinal (infraumbilical), and flank (left posterior flank at T12-L2). Each site will be measured five times using short-duration sensor reapplications to improve data precision. Concurrently, SpO2 and HR (via pulse oximetry), blood pressure, temperature, and subcutaneous fat thickness (via ultrasound) will be recorded. CRP and other laboratory parameters (including leukocyte count, IT-ratio) will be obtained as part of routine care on the first and second day after birth.
The primary aim is to identify the optimal cut-off level of the POP-Score, calculated within the first 6 hours, to predict CRP ≥20 mg/L within 48 hours. Receiver Operating Characteristic (ROC) analysis will be used, with the area under the curve (AUC) estimated and the optimal cut-off determined via the Youden Index.
Secondary aims include evaluating whether multi-site NIRS measurements (cerebral, peripheral muscle, intestinal, and flank) differ significantly between neonates with CRP ≥20 mg/L and those with CRP <20 mg/L, potentially offering additional early indicators of infection or inflammation.
The target sample size is 93 neonates, assuming a 20% incidence of CRP ≥20 mg/L. This allows estimation of the AUC with a 95% confidence interval and acceptable precision. Data will be analyzed using appropriate statistical tests for categorical and continuous variables. Statistical analyses will be conducted in cooperation with the Institute for Medical Informatics, Statistics, and Documentation, Medical University of Graz.
The POP-Score and multi-site NIRS monitoring offer a potentially powerful, non-invasive approach for early identification of at-risk neonates, enabling earlier intervention and improved outcomes. If validated, this tool may support more accurate and timely clinical decision-making in neonatal intensive care settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational cohort | – | Diagnostic Test: POP-Score Assessment, Device: Near-Infrared Spectroscopy (NIRS)This cohort includes term and moderate-to-late preterm neonates (birth weight ≥ 2000g) with respiratory distress within the first 6 hours after birth, admitted to the neonatal intensive care unit. All enrolled neonates undergo non-invasive monitoring to assess the predictive value of the POP-Score for identifying elevated CRP (≥20 mg/L) within the first 48 hours after birth. The cohort will also be analyzed to evaluate differences in multi-site NIRS measurements (peripheral muscle, cerebral, intestinal, and flank) between those with and without CRP elevation. |
Who may qualify
- Ages
- 0 to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Term and moderate-to-late preterm neonates (birth weight ≥ 2000 grams) with signs of respiratory distress within the first 6 hours after birth, admitted to the neonatal intensive care unit at the Medical University of Graz. All participants must have a gestational age allowing for clinical stability and must meet inclusion criteria including full life support decision and informed consent obtained within 6 hours of birth.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- No decision to conduct full life support
- No written informed consent
- Birth weight < 2000 grams
- Age > 6 hours
- Severe congenital malformations,
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 |
|---|---|---|
| POP-Score AssessmentA non-invasive score calculated within the first 6 hours after birth using peripheral muscle oxygenation (pTOI, measured via near-infrared spectroscopy), heart rate, arterial oxygen saturation (SpO2), systolic blood pressure (SABP), and subcutaneous fat layer thickness. The score is evaluated for its ability to predict C-reactive protein (CRP) levels ≥ 20 mg/L within 48 hours. | Diagnostic test | Observational cohort |
| Near-Infrared Spectroscopy (NIRS)NIRS measurements are performed within 6 hours after birth using the NIRO 200NX device at four anatomical sites (forearm, forehead, infraumbilical region, and left flank). Measurements assess peripheral muscle, cerebral, intestinal, and flank oxygenation to identify possible differences in tissue perfusion associated with early inflammation or infection. | Device | Observational cohort |
Primary outcome
Optimal Cut-Off Value of the POP-Score to Predict Elevated CRP (≥ 20 mg/L)
Time frame: Within the first 6 hours after birth (parameters of the POP-Score) and CRP within 48 hours
Determine the optimal cut-off value of the non-invasive POP-Score (unitless score), measured within the first 6 hours after birth, to predict elevated C-reactive protein (CRP) levels (≥ 20 mg/L) within the first 48 hours after birth in neonates with respiratory distress.
4 secondary outcomes
Difference in Peripheral Muscle Tissue Oxygenation by NIRS Between Neonates With and Without Elevated CRP
Time frame: NIRS within 6 hours after birth; CRP within 48 hours
Difference in Cerebral Tissue Oxygenation by NIRS Between Neonates With and Without Elevated CRP
Time frame: NIRS within 6 hours after birth; CRP within 48 hours
Difference in Intestinal Tissue Oxygenation by NIRS Between Neonates With and Without Elevated CRP
Time frame: NIRS within 6 hours after birth; CRP within 48 hours
Difference in Flank Tissue Oxygenation by NIRS Between Neonates With and Without Elevated CRP
Time frame: NIRS within 6 hours after birth; CRP within 48 hours
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 14 May 2026.
- Background: PubMed 22294473Pichler G, Pocivalnik M, Riedl R, Pichler-Stachl E, Zotter H, Muller W, Urlesberger B. C reactive protein: impact on peripheral tissue oxygenation and perfusion in neonates. Arch Dis Child Fetal Neonatal Ed. 2012 Nov;97(6):F444-8. doi: 10.1136/archdischild-2011-300578. Epub 2012 Jan 31.
- Background: PubMed 19775036Nanas S, Gerovasili V, Renieris P, Angelopoulos E, Poriazi M, Kritikos K, Siafaka A, Baraboutis I, Zervakis D, Markaki V, Routsi C, Roussos C. Non-invasive assessment of the microcirculation in critically ill patients. Anaesth Intensive Care. 2009 Sep;37(5):733-9. doi: 10.1177/0310057X0903700516.
- Background: PubMed 12507961Chiesa C, Pellegrini G, Panero A, Osborn JF, Signore F, Assumma M, Pacifico L. C-reactive protein, interleukin-6, and procalcitonin in the immediate postnatal period: influence of illness severity, risk status, antenatal and perinatal complications, and infection. Clin Chem. 2003 Jan;49(1):60-8. doi: 10.1373/49.1.60.
- Background: PubMed 29450194Pichler G, Holler N, Baik-Schneditz N, Schwaberger B, Mileder L, Stadler J, Avian A, Pansy J, Urlesberger B. Avoiding Arterial Hypotension in Preterm Neonates (AHIP)-A Single Center Randomised Controlled Study Investigating Simultaneous Near Infrared Spectroscopy Measurements of Cerebral and Peripheral Regional Tissue Oxygenation and Dedicated Interventions. Front Pediatr. 2018 Feb 1;6:15. doi: 10.3389/fped.2018.00015. eCollection 2018.
- Background: PubMed 19240298Grossauer K, Pichler G, Schmolzer G, Zotter H, Mueller W, Urlesberger B. Comparison of peripheral and cerebral tissue oxygenation index in neonates. Arch Dis Child Fetal Neonatal Ed. 2009 Mar;94(2):F156. doi: 10.1136/adc.2008.146654. No abstract available.
- Background: PubMed 17185431Pichler G, Grossauer K, Klaritsch P, Kutschera J, Zotter H, Muller W, Urlesberger B. Peripheral oxygenation in term neonates. Arch Dis Child Fetal Neonatal Ed. 2007 Jan;92(1):F51-2. doi: 10.1136/adc.2005.089037.
- Background: PubMed 21654025Pichler G, Pocivalnik M, Riedl R, Pichler-Stachl E, Morris N, Zotter H, Muller W, Urlesberger B. 'Multi-associations': predisposed to misinterpretation of peripheral tissue oxygenation and circulation in neonates. Physiol Meas. 2011 Aug;32(8):1025-34. doi: 10.1088/0967-3334/32/8/003. Epub 2011 Jun 7.
- Background: PubMed 18784432Pichler G, Wolf M, Roll C, Weindling MA, Greisen G, Wardle SP, Zaramella P, Naulaers G, Pellicer A, Austin T, Bartocci M, Urlesberger B. Recommendations to increase the validity and comparability of peripheral measurements by near infrared spectroscopy in neonates. 'Round table', section of haematology, oxygen transport and microcirculation, 48th annual meeting of ESPR, Prague 2007. Neonatology. 2008;94(4):320-2. doi: 10.1159/000151655. Epub 2008 Sep 11.
- Background: PubMed 26338668Holler N, Urlesberger B, Mileder L, Baik N, Schwaberger B, Pichler G. Peripheral Muscle Near-Infrared Spectroscopy in Neonates: Ready for Clinical Use? A Systematic Qualitative Review of the Literature. Neonatology. 2015;108(4):233-45. doi: 10.1159/000433515. Epub 2015 Aug 25.
- Background: PubMed 39115093Wolfsberger CH, Hoeller N, Baik-Schneditz N, Schwaberger B, Suppan E, Mileder LP, Avian A, Schlatzer C, Urlesberger B, Pichler G. Reference ranges of peripheral-muscle oxygenation in term neonates delivered by Caesarean section during immediate transition after birth. Acta Paediatr. 2024 Dec;113(12):2582-2589. doi: 10.1111/apa.17376. Epub 2024 Aug 8.
- Background: PubMed 38034828Wolfsberger CH, Holler N, Baik-Schneditz N, Schwaberger B, Suppan E, Mileder L, Avian A, Urlesberger B, Pichler G. Peripheral muscle fractional tissue oxygen extraction in stable term and preterm neonates during the first 24 h after birth. Front Pediatr. 2023 Nov 15;11:1276769. doi: 10.3389/fped.2023.1276769. eCollection 2023.
- Background: PubMed 23972642Pichler G, Binder C, Avian A, Beckenbach E, Schmolzer GM, Urlesberger B. Reference ranges for regional cerebral tissue oxygen saturation and fractional oxygen extraction in neonates during immediate transition after birth. J Pediatr. 2013 Dec;163(6):1558-63. doi: 10.1016/j.jpeds.2013.07.007. Epub 2013 Aug 22.
- Individual participant dataSharing planned: No
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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.
Gerhard Pichler, Prof contact
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 Prematurity, Infections and NIRS, 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 5 inclusion and 6 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 14 May 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 Christina H. Wolfsberger, MD, PhD (+43 316 385 81135, christina.wolfsberger@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal Cut-Off Value of the POP-Score to Predict Elevated CRP (≥ 20 mg/L) (time frame: Within the first 6 hours after birth (parameters of the POP-Score) and CRP within 48 hours). 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 NCT07109856, which also lists 18 linked publications.
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 14 May 2026.